Category: US Health

Source: US Department of Health and Human Services – 3

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.  
Affected Product
The FDA is aware that Medline has issued a letter to affected customers recommending certain convenience kits be removed from where they are used or sold. Affected devices:
Full list of Affected Products
What to Do
Remove affected BD ChloraPrep applicators. Apply over-labels to all affected kits on hand stating that the affected components must be removed and discarded prior to use.
On June 12, Medline sent all affected customers a letter recommending the following actions:

Immediately check your stock for any affected product and quarantine.  
Other components within the convenience kits may still be used.   
Apply provided over-labels to any affected kits on hand stating that the affected component must be removed and discarded prior to use.   
If you are a distributor or have resold or transferred this product, notify them of this recall communication.  

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.  
Reason for Alert
Medline stated that Becton, Dickinson and Company is conducting a Drug Recall of specific lots of the BD ChloraPrep™ Clear – 1 mL and FREPP™ Clear 1.5 mL Applicators due to a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening. Patients who may have been exposed should be monitored according to clinical judgment for signs or symptoms of infection, and any suspected infection should be evaluated and treated promptly. Patients who may have been exposed without complications do not require follow up.
As of June 12, Medline has reported no serious injuries or no deaths associated with this issue.
Device Use
Convenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures.  
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medline at recalls@medline.com or 866-359-1704.
Additional FDA Resources  

Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Content current as of:
07/09/2026

Regulated Product(s)

Source: US Department of Health and Human Services – 3

This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.  
Affected Product
The FDA is aware that Fresenius Kabi has issued a letter to affected customers recommending all infusion pumps be corrected prior to continued use. This issue affects the same devices and is separate from those described in the February 2026 communication, “Infusion Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Pump Software,” and the July 2026 communication, “Infusion Pump Correction: Fresenius Kabi Issues Correction for Dropped or Jarred Ivenix Large Volume Infusion Pumps.”
Affected devices:

Ivenix Large Volume Pump (LVP-0004)
Software Version 5.10.2 (LVP-SW-0005)
UDI: 00811505030320

What to Do
Units should be plugged in at all times instead of relying on battery power. 
On April 30, Fresenius Kabi sent all affected customers a letter recommending the following actions:

Keep the Ivenix pump plugged in at all times rather than relying on the battery, until a software update becomes available.
If a “Battery Extremely Low” alarm occurs while on battery, immediately connect the pump to AC. This alarm will shut down the pump within five minutes unless it is reconnected to AC mains power. If AC cannot be established before shutdown, transition therapy without delay using an alternate device, per clinical judgment and facility policy.
Transport Planning: For any transport of a patient on an affected pump, have a plan for AC access. For patients receiving critical or short half-life infusion therapies, ensure an RN accompanies the patient during transport.
Notify other users if applicable. If your facility distributes or transfers devices to other locations, notify all anticipated users of this correction.
Post the provided Safety Tip Sheet “Battery Health Software Anomaly in the Ivenix Large Volume Pump (LVP)” and the Urgent Medical Device Correction notice in all areas where affected pumps are stored and used.

Reason for Correction
Fresenius Kabi is voluntarily recalling Large Volume Pump Software, version 5.10.2 (Product Code LVP-SW-0005) embedded in the LVP-0004. This software introduced an anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power, presenting a remote but serious risk of patient harm.
Until a software update becomes available (expected July 2026), the Ivenix pump should remain plugged in at all times.
If the device unexpectedly shuts down due to the Battery Extremely Low alarm, therapy may be interrupted or delayed. Depending on the patient’s condition and the urgency of the therapy, such interruptions can reduce treatment effectiveness and may lead to serious health consequences. Patients at greatest risk include critically ill patients and patients receiving short half-life medications.
As of April 30, Fresenius Kabi has reported no serious injuries and no deaths associated with this issue.
Device Use
The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intravenous, intra-arterial, epidural, and subcutaneous, to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Fresenius Kabi Support at Ivenix_support@fresenius-kabi.com or (855) 354-6387.
Additional FDA Resources

Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Content current as of:
07/07/2026

Regulated Product(s)

Source: US Department of Health and Human Services – 3

This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.  
Affected Product

The FDA is aware that Fresenius Kabi has issued a letter to affected customers recommending all infusion pumps be corrected prior to continued use. This issue affects the same devices and is a separate from those described in the February 2026 communication, “Infusion Pump Software Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Pump Software” and the July 2026 communication, “Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump.”
What to Do
Do not use a device that has been dropped or severely jarred. Devices that have been dropped or severely jarred should be removed from use immediately, even if no damage is visible.
On April 30, Fresenius Kabi sent all affected customers a letter recommending the following actions:

If a unit has been dropped or severely jarred, remove it from service, even if no damage is visible.
Once the pump has been removed from service, or if you have questions about whether to do so after a drop, contact Fresenius Kabi customer support at Ivenix_support@fresenius-kabi.com or (855) 354-6387.
Follow the actions outlined in the “Proper Handling of the Ivenix Large Volume Pump (LVP)” Safety Tip Sheet, included in Fresenius Kabi’s Urgent Medical Device Correction notice. This tip sheet provides temporary instructions until Fresenius Kabi updates the IFU to clarify that devices dropped or severely jarred must be taken out of service.

Reason for Correction
Fresenius Kabi stated that the pump touchscreen may display unintended behaviors, including random screen touches and lack of screen responsiveness to user input. In most cases, this behavior is the result of a loosened touchscreen input cable. 
Testing confirmed that the cable became loose when these units were dropped on a hard surface or experienced severe jarring. These events did not necessarily cause visible damage but were of sufficient force to loosen the cable.
Unintended touchscreen behavior on the pump, such as random screen touches or lack of responsiveness, can affect the user’s ability to manage therapy. This could lead to an interruption or delay of therapy. Such occurrences may lead to adverse health consequences, including the risk of serious injury or death.
As of May 6, Fresenius Kabi has reported two serious injuries and no deaths associated with this issue.
Device Use
The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intravenous, intra-arterial, epidural, and subcutaneous, to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Fresenius Kabi Support at Ivenix_support@fresenius-kabi.com or (855) 354-6387.
Additional FDA Resources

Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Content current as of:
07/07/2026

Regulated Product(s)

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
July 06, 2026
FDA Publish Date:
July 07, 2026
Product Type:
Food & BeveragesAllergens
Reason for Announcement:

Recall Reason Description
May contain undeclared milk in the form of sodium caseinate

Company Name:
Fayus, Inc.
Brand Name:

Brand Name(s)
Ola-Ola

Product Description:

Product Description
Pounded Yam

Company Announcement
Fayus Inc., doing business as Yusol International Foods (Sacramento, CA) is voluntarily recalling OLA-OLA POUNDED YAM because the product may contain undeclared milk in the form of sodium caseinate, which is not declared on the label.
The recall is being initiated as a result of an internal investigation discovering that some packaged OLA-OLA POUNDED YAM had been distributed in packaging that did not disclose the presence of sodium caseinate – derived from milk (dairy) allergen. A subsequent investigation found that the issue resulted from a temporary breakdown in the company’s production and packaging processes. People who have an allergy or severe milk sensitivity to milk run the risk of a serious or life-threatening allergic reaction if consumed. No illness or injuries have been reported to date in connection with this issue.
OLA-OLA POUNDED YAM was distributed through distribution outlets between December 2025 – May 2026 in Canada, Australia and the following United States:

California
Georgia
Illinois
New Jersey
New York
Texas

The recalled product is packaged in a clear bag – see attached picture. The recalled product can be identified by the expiration dates: November 2028 through May 2029. Consumers should check expiration date on the front of the packaging. This recall only applies to products with expiration dates from November 2028 through May 2029 with the dairy allergen not listed.
Fayus Inc. is working to apply dairy allergen warning stickers to affected products that remain on store shelves.
Questions or Exchange Requests:
Consumers with a milk allergy or sensitivity should not consume the affected product. They may return it to the place of purchase for an exchange for a correctly labeled product or warning sticker labeled product. Fayus Inc. apologizes for any inconvenience and remains committed to the safety and quality of its products.

Product Photos

Content current as of:
07/07/2026

Regulated Product(s)

Topic(s)

Follow FDA

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
July 03, 2026
FDA Publish Date:
July 06, 2026
Product Type:
Food & BeveragesFoodborne Illness
Reason for Announcement:

Recall Reason Description
Possible E. Coli Contamination

Company Name:
Frutas y Hortalizas del Sur S.A.
Brand Name:

Brand Name(s)
GreenWise

Product Description:

Product Description
Organic IQF Frozen Blueberries 10 oz

Company Announcement
July 3, 2026 – Frutas y Hortalizas del Sur S.A., San Carlos, Chile is recalling frozen GreenWise Organic IQF Blueberries 10 oz. Because it may be contaminated with Escherichia coli O145:H28 (E. coli O145).
E. coli O145 is a Shiga toxin-producing E. coli (STEC) that can cause illness characterized by severe stomach cramps, diarrhea (which may be bloody), and vomiting. While most healthy individuals recover within a week, some infections may result in a serious complication known as hemolytic uremic syndrome (HUS), particularly in young children, older adults, and individuals with weakened immune systems.
The recalled product was shipped to Publix retail stores throughout 8 states including Alabama, Florida, Georgia, Kentucky, North Carolina, South Carolina, Tennessee, and Virginia. Consumers should check their freezers for the affected product.
The affected product lot is:

Product: Frozen GreenWise Organic IQF Blueberries
Package Size: 10 oz
Lot Code: 60401
Best By Date: February 9, 2028

No other lot codes or Best By dates are affected by this recall.
There have been reports of 12 confirmed cases of consumers experiencing stomach illness between May 11, 2026 and June 5, 2026 linked with E. coli O145:H28 infections
After receiving reports of consumers experiencing digestive illnesses and having consumed GreenWise frozen blueberries as part of their diet, Frutas y Hortalizas S.A. has decided to initiate the recall.
Consumers who have frozen GreenWise blueberry products with the affected lot date should not consume it. The product should be discarded or returned to the place of purchase for a full refund.
Frutas y Hortalizas S.A. is working closely with the appropriate regulatory authorities and its customers regarding this recall. The company has instructed all customers receiving the affected lot to immediately isolate the product, discontinue its distribution, and notify any downstream customers who may have received the affected lot.
Food safety remains a top priority for Frutas y Hortalizas S.A. The company is committed to protecting consumers and is conducting a thorough investigation into the source of the presumptive finding. Additional information will be provided as it becomes available.
Consumers or customers with questions regarding this recall may contact:
Info.foodsafety@comfrut.com or 336-899-5612
Monday – Friday 8 AM – 6 PM EST
Media Contact
Joshua WeissEmail: joshua.weiss@comfrut.com

Company Contact Information

Product Photos

Content current as of:
07/06/2026

Regulated Product(s)

Topic(s)

Follow FDA

Source: US Department of Health and Human Services – 3

The affected products and recommendations for what to do with the devices below have not changed. 
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
The FDA is aware that Windstone Medical Packaging, Inc., has issued a letter to affected customers recommending certain custom convenience kits be corrected prior to continued use by removing Cardinal Health Webcol large alcohol prep pads.
Affected convenience kits:

Affected components contained within the convenience kits:

Component Name
Cardinal Health Part Number
Aligned Medical Solutions Part Number
Component Lot Number

Webcol Large Alcohol Prep Pad
5110
69124
25K006462

Full List of Affected Products
What to Do
Apply the Aligned Medical Solutions over-label (see Recall Notice image below) to affected inventory. When the affected convenience kits are opened for use, remove, discard and do not use the Cardinal Health Webcol Alcohol Prep Pads.
On May 21, 2026, Aligned Medical Solutions sent all affected customers a letter recommending the following actions:

Identify affected products.
Apply the provided over-labels according to the instructions provided.
When affected kits are opened for use, remove any Cardinal Health Alcohol Prep Pads.
Mark on the removed pads that they are to be disposed of and set them aside for disposal. 
Dispose of the recalled pads following medical waste policies at your institution.
Request replacement product as needed.

Reason for Correction
Windstone Medical Packaging initiated an Urgent Medical Device Recall notice for convenience kits that contain Cardinal Health alcohol pads affected by a Cardinal Health Nationwide Recall. The Alcohol Prep Pads may be contaminated with Paenibacillus phoenicis. Use of contaminated pads for skin preparation before injections or blood draws poses risk of infection to vulnerable groups such as critically ill, immunocompromised, neonatal, and pediatric patients.
As of June 4, 2026, Windstone Medical Packaging has reported no serious injuries or deaths associated with this issue.
Device Use
The convenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Windstone Medical Packaging, Inc. at jjensen@alignedmedical.com or call (407) 638-9924.
Additional FDA Resources

FDA Enforcement Report
CDRH Medical Device Recall Database
Cardinal Health Large Alcohol Pad Recall: FDA Enforcement Report

Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?  
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Timeline of Communication Updates

Date
Actions

07/06/2026
The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall.

06/16/2026
The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue.

Content current as of:
07/06/2026

Regulated Product(s)

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
July 02, 2026
FDA Publish Date:
July 02, 2026
Product Type:
Animal & VeterinaryFood & BeveragesPet Food
Reason for Announcement:

Recall Reason Description
Potential foreign plastic contamination

Company Name:
Mars Petcare US, Inc.
Brand Name:

Brand Name(s)
Pedigree

Product Description:

Product Description
High Protein Chopped Chicken & Duck Flavor Wet Dog Food

Company Announcement
FRANKLIN, Tenn., (July 2, 2026): Mars Petcare US, Inc. is issuing a voluntary recall for two lots of PEDIGREE® Can High Protein Chopped Chicken & Duck Flavor 13.2oz for dogs.
The recalled products did not meet Mars and PEDIGREE stringent safety and quality standards. As part of the robust quality control process every single PEDIGREE product undergoes, these two lots had been sent to a third-party vendor for destruction. Mars later discovered that the product appears to have been fraudulently diverted and sold into the marketplace in the United States.
The recalled product may contain metal and plastic foreign material. The potential presence of sharp metal and plastic foreign material in the cans could pose a hazard to your dog. Health risks to dogs ingesting sharp foreign objects can range from choking to lacerations or blockages in the gastrointestinal tract. Consumers who fed the recalled product to their dog and are concerned should contact their veterinarian.
Mars is working with authorities to determine how these products entered the marketplace. We are committed to protecting pets and helping consumers identify and remove the affected products from use. We have received no related reports of pet illness or injury to date.
How to Identify Impacted ProductsThis recall applies ONLY to the two lot codes of product below:

Product: PEDIGREE® Can High Protein Chopped Chicken & Duck Flavor 13.2oz for dogs
Lot codes: 613C3KKCFC & 613C1KKCFC
Safety Risk: Pieces of hard and sharp metal with plastic may be present and could cause harm if consumed.

If you believe you have purchased this product, do not feed it to animals, and contact PEDIGREE for a replacement product.
No other PEDIGREE or Mars Petcare US, Inc. products are affected or being recalled.
Contact informationContact PEDIGREE Consumer Care to initiate a replacement or with any questions at 1-800-525-5273, Monday through Friday from 8:00 AM to 8:00 PM Central Standard Time (CDT), and Saturday and Sunday from 8:00AM to 4:00PM (CDT). You can also visit: https://www.pedigree.com/update.
How do I find my lot number?See Images Below

Company Contact Information

Consumers:
1-800-525-5273

Product Photos

Content current as of:
07/02/2026

Regulated Product(s)

Follow FDA

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
July 02, 2026
FDA Publish Date:
July 02, 2026
Product Type:
Food & BeveragesAllergens
Reason for Announcement:

Recall Reason Description
Product contains undeclared fish (tuna)

Company Name:
Gellert Global Group
Brand Name:

Brand Name(s)
Fusia

Product Description:

Product Description
Kimchi & Tofu Kimbap

Company Announcement
Gellert Global Group of Elizabeth, NJ is recalling 8.1 oz packages of ALDI Brand Fusia Asian Inspirations Kimchi & Tofu Kimbap because they may contain undeclared fish (tuna). People who have an allergy or severe sensitivity to fish run the risk of serious or life-threatening allergic reaction if they consume these products.
The recalled Fusia Asian Inspirations Kimchi & Tofu Kimbap was distributed in select ALDI retail stores in the states of Connecticut, Washington DC, Delaware, Louisiana, Maryland, Maine, Massachusetts, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, West Virginia.
The product is packaged in a 8.1 oz sealed, microwave-safe plastic wrapper and marked with a BEST IF USED BY DATE of OCT.08.2027.
No illnesses have been reported to date in connection with this problem.
The recall was initiated after a consumer discovered that the fish-containing product was distributed in packaging that did not reveal the presence of fish. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging procedures that has subsequently been corrected.
Consumers who have purchased the 8.1 oz packages of ALDI Brand Fusia Asian Inspirations Kimchi & Tofu Kimbap are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-908-351-8000 Monday-Friday 8:30 am-5:00 pm EST or email fsqaincidents@gellertglobalgroup.com.

Company Contact Information

Product Photos

Content current as of:
07/02/2026

Regulated Product(s)

Topic(s)

Follow FDA

Source: US Department of Health and Human Services – 3

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. The affected products and recommendations for what to do with the devices below have not changed.
Affected Product
The FDA is aware that Abiomed has issued a letter to affected customers recommending certain Impella CP Sets with SmartAssist be removed from where they are used or sold.
Affected devices:

Product Description: Impella CP Set with SmartAssist
Product Code: 0048-0003
UDI-DI: 00813502012279
Impacted Serial Numbers: 613525, 644314, 645428, 644591, 672986, 673252, 677223

What to Do
Do not use affected products. Review inventory for affected serial numbers and return to Sedgwick.
On May 18, Abiomed sent affected customers a letter recommending the following actions:

Review all Impella CP Sets within inventory and quarantine any affected sets.
Return affected product to Sedgwick.
Share this information with anyone in your facility who manages, transports, stores, stocks, or uses these devices.
Post a copy of the notice in a visible area for awareness.

Reason for Recall
Abiomed stated that specific distributed units of Impella CP with SmartAssist do not meet design specifications. This out-of-specification may result in low purge pressure events from the onset of the case.
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support. Loss of support may lead to an acute change in care when the pump is exchanged, hypotension, end organ hypoperfusion, and risk of death if not promptly corrected.
As of May 7, Abiomed has reported three pump exchanges, which have the potential to result in serious injuries and one death associated with this issue.
Device Use
The Impella CP with SmartAssist Catheter is indicated for providing temporary ventricular support during elective or urgent high risk percutaneous coronary interventions (PCI) performed in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Abiomed at OneMD-Field Actions@its.jnj.com.
Additional FDA Resources

FDA Enforcement Report
CDRH Medical Device Recall Database

Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Timeline of Communication Updates

Date
Actions

07/02/2026
The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall.

05/27/2026
The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue.

Content current as of:
07/02/2026

Regulated Product(s)

Source: US Department of Health and Human Services – 3

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. The affected products and recommendations for what to do with the devices below have not changed. 
Affected Product
The FDA is aware that Insulet has issued a letter to affected customers recommending certain Omnipod Pods be removed from where they are used or sold. Affected devices:

Omnipod 5 Automated Insulin Delivery System 
Omnipod DASH Insulin Management System 
Omnipod Insulin Management System (Omnipod Eros) 
Full List of Affected Product

What to Do
Do not use Pods from affected lots. Check all Pods to determine if they are affected. If you are currently using a Pod from an affected lot, immediately change your Pod to resume insulin delivery. If you do not have enough Pods due to this issue, talk to your healthcare provider about other methods of insulin delivery.
On May 26, Insulet sent all affected customers a letter recommending the following actions:

DO NOT use Pods from the affected lots. 

Check the lot number on your Pod tray lid, the Pod box or the Pod itself to determine if your Pods are affected. 
Follow Insulet’s instructions and pictures to help identify the lot number for your Pods 
Review the lot list to determine whether your Pod is impacted.  
All Pods within a single box will be from a single lot and if the lot is affected, do not use any of those Pods. 

If your Pods are impacted: 

Discontinue use of any impacted Pod immediately. If the Pod you are currently using is from an affected lot, it is important that you immediately change your Pod to resume insulin delivery. When changing your Pod, confirm that the new Pod is not from an affected lot.  
Follow the instructions provided by Insulet in their customer email to acknowledge that your Pod is impacted and request a replacement.  
For additional information, call Insulet’s Product Support phone line at 1-800-641-2049, available 24/7. 

Users will receive a return kit with clear instructions on how to send back any unused affected Pods.  
Always check the expiration date before using a Pod. Do not use any Pod that is past its expiration date, as expired Pods may not function as intended. 
If your Pod supply is depleted due to this issue, consult with your healthcare provider for alternative means of insulin delivery while waiting for Pods to be replaced. Always follow your healthcare provider’s guidance on appropriate glucose monitoring. 

Reason for Recall
Insulet identified that some Pods from specific lots may have a small tear in the tubing (cannula) just above the skin, between the Pod and the point where the cannula enters the body.  If this occurs, insulin may leak outside of the Pod instead of being fully delivered into the body as intended, potentially leading to under-delivery of insulin.  If you are using an affected Pod, you may notice wetness on your skin or Pod adhesive or detect the smell of insulin. However, in some cases, this may be difficult to detect and may go unnoticed.  
If insulin leakage occurs, your blood glucose levels may rise and may not respond as expected to insulin delivery. If using Omnipod 5, and it is in Automated Mode, this could trigger an Automated Delivery Restriction alert, advising you to troubleshoot. However, this issue may happen without triggering any alert, meaning you could receive less insulin than needed without realizing it. Do not rely only on Pod alerts to know if something is wrong.
If insulin is not delivered properly, you may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment and can be life-threatening if not treated.
Note that this issue does not affect continuous glucose monitoring (CGM) systems or CGM readings.
As of May 20, Insulet has reported 24 serious injuries and no deaths associated with this issue.
Device Use
Omnipod is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Insulet at https://www.omnipod.com/current-podders or call 1-800-641-2049.
Additional FDA Resources

FDA Enforcement Report
CDRH Medical Device Recall Database

Additional Company Resources  
Company-provided information is posted here by the FDA as a public service.  

Insulet Corporation – Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® Pods in the U.S. and Affected International Markets  [05/26/2026]   
Urgent Medical Device Correction | Omnipod [05/26/2026]  

Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Timeline of Communication Updates  

Date
Actions

07/02/2026
The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall.

06/04/2026
The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue. 

Content current as of:
07/02/2026

Regulated Product(s)