First Aid Kit Recall: North American Rescue Issues Correction for First Aid Kits Containing TRUE METRIX Devices

Source: US Department of Health and Human Services – 3

The FDA has provided recommendations for patients, caregivers, and health care providers in the “Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health” FDA Safety Communication. The FDA has identified this recall as a Class I, the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.    
Affected Product
The FDA is aware that North American Rescue has issued a letter to affected customers recommending first aid kits be corrected prior to continued use.
Affected devices:

Product Description
Product Code 
Lot Number

KIT, AIDBAG – SMALL – CRISIS 24
85-4661
85-4661122024

KIT, AIDBAG 1 – V1.0 – SEATTLE PD
85-4742
 85-4742123024

What to Do
The FDA recommends that consumers and health care providers follow the recommendations provided in the “Risks of Using TRUE METRIX Blood Glucose Monitoring Systems by Trividia Health” FDA Safety Communication, issued April 28.
North American Rescue sent an Urgent Medical Device Correction letter on March 27 to notify affected customers of the issue.
Reason for Recall
North American Rescue initiated an Urgent Medical Device Correction for first aid kits that contain blood glucose monitors affected by Trividia’s TRUE METRIX Blood Glucose Monitoring System recall.
The Trividia recall is for an issue with the E-5 error code and the instructions for the user in the “Messages” section of the Owner’s Booklets/System Instructions for Use and the online labeling and help guides. The TRUE METRIX meters display the same E-5 Error Code for two different types of issues: 1) a very high blood glucose event (> 600 mg/dL), and/or 2) when there is a test strip error. If a user receives an E-5 Error Code when they are having a very high glucose event, they may not seek appropriate treatment if they think it is a test strip error, or they may delay appropriate treatment as they try to determine what the error means. Alternately, if a user assumes the E-5 Error Code is due to a very high blood glucose event, but they actually have low or normal blood glucose, they may improperly treat themselves for high blood glucose when they actually have low or normal blood glucose.  Either a delay in treatment or improper treatment may result in serious adverse health consequences, such as dehydration, altered mental status, loss of consciousness, or death, especially for users with very high or very low blood glucose levels. Trividia has reported 114 serious injuries and one death associated with this recall.
As of March 27, North American Rescue has not reported any serious injuries or deaths associated with this issue.
Device Use
The North American Rescue first aid kits are intended to be used by emergency medics to help during various health emergencies.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Trividia Health at trividia0126CC@trividiahealth.com or call (888) 835-2723.
Additional FDA Resources

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:
06/26/2026

Regulated Product(s)

FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health

Source: US Department of Health and Human Services – 3

For Immediate Release:
June 26, 2026

The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would help protect the public health of Americans, including youth, by strengthening the agency’s ability to efficiently identify illegal foreign tobacco products — including youth-appealing e-cigarettes — and conduct on-site inspections abroad.  
Domestic tobacco product manufacturers are currently required under federal law to register their establishments and list their products with the FDA. In contrast, foreign tobacco product manufacturers are not subject to these requirements unless and until the FDA mandates their registration and product listing through regulation. This proposed regulation would implement this requirement, closing this regulatory gap. With a more complete picture of the products manufactured for sale to American consumers and where they come from, FDA can better protect public health and more efficiently identify and take action on unauthorized tobacco products such as e-cigarettes that are imported and illegally sold in the U.S.
Under the proposed rule, titled “Establishment Registration and Product Listing for Tobacco Products,” the FDA would prescribe the format, content, and procedures for establishment registration and tobacco product listing. This would include both foreign and domestic establishments that manufacture, prepare, compound, or process tobacco products.  
“All companies selling tobacco products in the United States should play by the same rules,” said Bret Koplow, Ph.D., J.D., Acting Director of the FDA’s Center for Tobacco Products. “The FDA is working hard to close the gap between domestic and foreign companies, level the playing field for American businesses, and ensure that all manufacturers are held to the same standards.”  
The FDA has existing authority to enforce against illegal tobacco products and has taken action on products manufactured abroad, including recent record-breaking seizures of unauthorized e-cigarettes. If finalized, this proposed rule would significantly expand the agency’s knowledge of tobacco products manufactured abroad for import into the U.S. and allow the agency to be more proactive.  
The proactive establishment registration, systematic inspections, and product surveillance included in this proposed regulation would give the FDA significantly more tools to identify and act against illegal foreign tobacco products. For unauthorized e-cigarettes, many of which are manufactured outside the U.S., this is a critical step forward for protecting public health.
“If finalized, this proposed rule would strengthen the FDA’s ability to enforce against illegal foreign tobacco products that may threaten the health and safety of Americans, including youth,” Dr. Koplow added. “By inspecting foreign manufacturing facilities, we can verify compliance at the source and stop illegal products before they reach American consumers.”
The rule, if finalized, would also require all manufacturers to maintain product labeling, advertising, and consumer information records for at least four years after their use. The FDA could then more easily verify compliance with labeling and advertising requirements and ensure that products are not marketed in ways that, for example, appeal to youth or make unauthorized health claims.
Additionally, this rule would require all manufacturers to provide information to uniquely identify each tobacco product, including products’ FDA-assigned Submission Tracking Number, nicotine concentration and source, characterizing flavors, package sizes and types, and product dimensions. For e-cigarettes, manufacturers would also need to provide specifications such as e-liquid volume, battery capacity, and wattage.  
To streamline and increase efficiency, in most cases manufacturers would be required to submit information electronically through the FDA’s online system, enabling them to register more quickly. They would also be required to review and update their establishment registrations annually and their product listings twice a year to ensure the agency has current information.
The proposed rule is available for public comment. Submit your comments by Sept. 14, 2026, at Regulations.gov. The agency will review all comments as part of the rulemaking process.
Related Information

Related Information

Consumer:888-INFO-FDA

###

Boilerplate

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.

Revival Animal Health, LLC Voluntarily Recalls Canine and GM Milk Replacers Due to Low or Elevated Levels of Vitamin D

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
June 25, 2026
FDA Publish Date:
June 25, 2026
Product Type:
Animal & VeterinaryFood & BeveragesIngredients
Reason for Announcement:

Recall Reason Description
Variable levels of Vitamin D

Company Name:
Revival Animal Health
Brand Name:

Brand Name(s)
Breeder’s Edge, Shelter’s Choice

Product Description:

Product Description
Canine milk replacer

Company Announcement
Revival Animal Health of Orange City, IA is recalling Breeder’s Edge® Foster Care® Canine, Shelter’s Choice® Canine Milk Replacers, and is expanding the current recall to include the Breeder’s Edge® Foster Care® GM (goat milk) products due to variable levels of Vitamin D resulting in either low or elevated levels in the milk replacers.
Consumers should stop feeding the products listed below to their dogs.
Dogs ingesting elevated levels of Vitamin D may exhibit symptoms such as vomiting, diarrhea, loss of appetite, weakness, lethargy, reduced growth, and weight loss. Vitamin D when consumed at very high levels can lead to calcification of soft tissues, such as the kidney. Puppies ingesting low levels of Vitamin D over several weeks may develop lethargy, weakness, bone deformities, painful, swollen joints and lameness due to weakened or malformed bones (rickets). Consumers who have dogs that have consumed any of the affected products and are exhibiting these symptoms should contact their veterinarian.
Affected recalled products were sold nationwide through online and in retail pet stores. Products are packaged in multiple sizes of stand-up resealable bags and 12 oz jars. A full list of affected products is below:

Product Name

Net Weight

UPC

Best by Range

Breeder’s Edge Foster Care GM Milk Replacer

1 lb.

817160010080

01/08/2028, 06/25/2027

Breeder’s Edge Foster Care GM Milk Replacer

5 lb.

817160010097

01/08/2028, 06/25/2027

Shelter’s Choice Canine Milk Replacer

1 lb.

817160011087

6/19/2026,   9/9/2026,1/16/2027,   11/14/2027

Shelter’s Choice Canine Milk Replacer

3.5 lb.

817160011070

6/19/2026,   10/31/2026,11/14/2027,   1/20/2028

Shelter’s Choice Canine Milk Replacer

8 lb.

817160011056

6/19/2026,   9/9/2026,11/14/2027,   1/20/2028

Breeder’s Edge Foster Care Canine Milk Replacer

12 oz

817160010189

7/11/2026,   8/15/2026,9/9/2026,   4/3/2027,5/1/2027,   2/5/2028,

Breeder’s Edge Foster Care Canine Milk Replacer

18 lb.

817160011025

7/11/2026,   9/9/2026,1/16/2027,   4/3/2027,4/29/2027,   11/14/2027,1/20/2028

Breeder’s Edge Foster Care Canine Milk Replacer

20 lb.

817160010172

6/19/2026

Breeder’s Edge Foster Care Canine Milk Replacer

4.5 lb.

817160010073

5/22/2026,   9/9/2026,10/31/2026,   3/7/2027,4/29/2027,   11/14/2027,2/5/2028

Two complaints of rickets have been reported to date.
The recall was expanded to include the Breeder’s Edge Foster Care GM (goat milk) products after testing confirmed elevated levels of Vitamin D. Revival Animal Health is reviewing the manufacturer relationship and will not distribute the milk replacement products until we are confident in their safety.
This recall is being made with the knowledge of the U.S. Food and Drug Administration.
Consumers who have purchased the affected product should discontinue use immediately and contact the company to return for a full refund. Consumers with questions may contact the company at 1-877-870-4059 hours (M-F 8 am- 4 pm CDT time).
Link to Original Press Release

Company Contact Information

Consumers:
1-877-870-4059

Product Photos

Content current as of:
06/25/2026

Regulated Product(s)

Topic(s)

Follow FDA

Lehi Valley Trading Company Issues Allergy Alert on Undeclared Peanuts in Chocolate Covered Raisins

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
June 25, 2026
FDA Publish Date:
June 25, 2026
Product Type:
Food & BeveragesAllergens
Reason for Announcement:

Recall Reason Description
May Contain Undeclared Peanuts

Company Name:
Lehi Valley Trading Company
Brand Name:

Brand Name(s)
High Valley Orchard

Product Description:

Product Description
Chocolate Covered Raisins

Company Announcement
June 25, 2026, Lehi Valley Trading Company of Mesa, AZ, is recalling 624 units of its 15 ounce packages of High Valley Orchard Chocolate Covered Raisins because they contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume this product.
The recalled Chocolate Covered Raisins were distributed in retail stores through Albertson’s distribution center between 5/18/2026 and 6/25/2026.
The product comes in a 15 ounce, clear plastic package marked with lot # 0160933, best by date of Jan 23, 2027, on the bottom right-hand side of the front label.
No illnesses or deaths have been reported to date in connection with this problem to date.
The recall was initiated after the presence of peanuts were discovered in the Chocolate Covered Raisins. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s production and packaging processes.
Consumers who have an allergy or severe sensitivity to peanut are urged to not consume product and should discard or return product to the place of purchase for a full refund. Consumers with questions may contact the company at 480-962-5017, Monday – Friday, 8am-5pm PST.

Company Contact Information

Consumers:
480-962-5017

Product Photos

Content current as of:
06/25/2026

Regulated Product(s)

Topic(s)

Follow FDA

Calendar Year (CY) 2027 End-Stage Renal Disease (ESRD) Prospective Payment System Proposed Rule

Source: US Department of Health and Human Services

Calendar Year (CY) 2027 End-Stage Renal Disease (ESRD) Prospective Payment System Proposed Rule – CMS-1846-P

On June 24, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update payment rates and policies under the Medicare End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2027. This rule also proposes updates to the acute kidney injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2027 and proposes to update requirements for the ESRD Quality Incentive Program (QIP).

Infant Resuscitation System Correction: GE HealthCare Issues Correction for Giraffe and Panda Infant Resuscitation Systems and Warmers with a M1091607-R Blender

Source: US Department of Health and Human Services – 3

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. The affected products and recommendations for what to do with the devices below have not changed. 
Affected Product

The FDA is aware that GE HealthCare has issued a letter to affected customers recommending Infant Resuscitation Systems and Warmers with a M1091607-R blender be corrected prior to continued use.
Affected devices:

Product Name
Ref Number
GTIN

Giraffe6 Stand-Alone Infant Resuscitation System
2082663-0012082663-002M1241424
00840682100151 00840682100175 

Giraffe6 Warmer with Integrated Resuscitation System (iRes)
M1118179
00840682103923

Panda Warmer with Integrated Resuscitation System (iRes) 
M1112198
V2.0 (Hybrid) 00840682152716 V1.0 (US) 00840682152709

Panda Freestanding Warmer
2063568-001
00840682103916

Service Blender Includes Standoffs and Knob
M1091607-R
N/A

Full List of Affected Blender Serial Numbers
What to Do
Identify and remove affected devices from use until they can be corrected. If affected devices must be used prior to correction, follow the additional precautions below.
On May 8, GE HealthCare sent all affected customers a letter recommending the following actions:

Inspect all Giraffe and Panda Warmers with Integrated Resuscitation System (iRes) and Giraffe Stand-alone Infant Resuscitation System devices to determine if the device has an affected blender. 
If the device has an affected blender, remove the unit from patient use and contact a GE HealthCare Service Representative at the number listed below. 
If a device with an affected blender must be used prior to being corrected by GE HealthCare, follow the instructions below: 

Follow the instructions in the device User Manuals, including all pre-use checkout instructions. These manuals also include the following requirements and warnings: 

Pre-use checkout: Before each operation, inspect the resuscitation system for damage, such as broken knobs and fittings or gauges with indicator needles that are not at 0. 
Do not do the pre-use checkout procedure, service, or calibrate the device with the patient in the device. Make sure all pre-use checkout procedure steps are correctly completed before each patient use. If a step fails, do not use the device. 

Perform the blender Multipoint Oxygen Concentration Check as described in Section 2.5.1 of the Service Manual M1128929. 
If the pre-use checkout passes and the Multipoint Oxygen Concentration Check meets specifications, GE HealthCare recommends oxygen concentration should be verified with an independent oxygen analyzer on a frequent basis until the unit is corrected. 
If the pre-use check does not pass (e.g., the blender knob is loose) or the Multipoint Oxygen Concentration Check does not meet specifications, remove the unit from patient use. 
Note: User and service manuals are available on the Customer Documentation Portal: https://www.gehealthcare.com/support/manuals

Evaluate existing service stock for affected blenders. The blender model number and serial number are visible on the packaging. The serial number is visible on the blender. Quarantine any affected blenders.

Reason for Correction
GE HealthCare stated that the air-oxygen blender knob shaft on certain integrated and stand-alone Resuscitation systems can loosen, which can affect the delivered oxygen concentration. If this occurs, the system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.
As of May 20, GE HealthCare has not reported any serious injuries or deaths associated with this issue.
Device Use
The Integrated Resuscitation and Standalone Infant Resuscitation Systems provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures during manual ventilation to the infant.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact GE HealthCare Service at 1-800-437-1171.
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

06/22/2026
The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall.

06/05/2026
The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue. 

Content current as of:
06/22/2026

Regulated Product(s)

MorningStar Farms Voluntarily Recalling Two Varieties Due to Possible Plastic Presence

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
June 18, 2026
FDA Publish Date:
June 22, 2026
Product Type:
Food & Beverages
Reason for Announcement:

Recall Reason Description
Possible plastic pieces in the food

Company Name:
Morningstar Farms
Brand Name:

Brand Name(s)
Morningstar Farms

Product Description:

Product Description
Plant Based Buffalo Chik’n Nuggets and Hot and Spicy Sausage Patties

Company Announcement
CHICAGO, June 18, 2026 – MORNINGSTAR FARMS is voluntarily recalling two varieties of products in the U.S., Puerto Rico and Costa Rica because of possible plastic pieces in the food. Recalled varieties are: MORNINGSTAR FARMS Buffalo Chik’n Nuggets (10.5 oz) and MORNINGSTAR FARMS Hot & Spicy Sausage Patties (8 oz).
No other MORNINGSTAR FARMS brand products are affected by the recall.
HOW TO IDENTIFY THE RECALLED PRODUCT
The affected U.S. products include the following variety:

Description

UPC Codes

Size

Better if Used Before Date

MORNINGSTAR FARMSBuffalo Chikn’n Nuggets

000 28989 10110 5

10.5 oz

July 07 2027 July 08 2027

MORNINGSTAR FARMS Hot and Spicy Sausage Patties

000 28989 10094 8

8.0 oz

July 05 2027 July 06 2027 July 07 2027

People who purchased affected product should discard it and contact the company for a full refund.
Consumers can contact Consumer Affairs Monday through Friday, 9 AM to 6 PM EST, by calling 800-962-0120 or texting 877-453-5837.

Company Contact Information

Consumers:
Consumer Affairs
800-962-0120

Content current as of:
06/22/2026

Regulated Product(s)

Follow FDA

Heart Pump Controller Correction: Abiomed Updates Use Instructions for Automated Impella Controllers

Source: US Department of Health and Human Services – 3

This recall involves updating instructions for using 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 following the updated instructions. The Reason for Correction section has been updated for clarity. The affected products and recommendations for what to do with the device below have not changed. 
Affected Product

The FDA is aware that Abiomed has issued an Urgent Medical Device Recall (Correction) notice to affected customers recommending updated use instructions for all Automated Impella Controllers (AIC). 
Affected devices:

Product Code
Product Description
UDI-DI

0042-0000-US
Impella Controller, Packaged, US
00813502010022

0042-0010-US
Impella Optical Controller, Packaged, US
00813502010985

0042-0040-US
Optical, AIC, Impella Controller, Pkgd, US
00813502011401

Full List of Affected Product 
What to Do
Be aware that a software error may cause the AIC to restart when used in conjunction with left ventricular Impella devices.On May 14, Abiomed sent all affected customers a letter recommending the following actions:

In the scenario of extended (>80 min) lack of pulsatility (< 12 mmHg), followed by a sudden change in LV pressure an AIC console restart will occur during support levels greater than P-3. Additional hemodynamic support may be required in this hemodynamically compromised population. If such an episode is encountered, a console exchange is unnecessary as the phenomenon will recur on the exchange device. In patients additionally supported with veno-arterial ECMO, unloading of the ventricle at a level of support of P-3 or lower will avoid the restart from happening as the LVP calculator causing the issue is off. Forward Abiomed’s notice to anyone in your facility that needs to be informed and post a copy of the notice in a visible area for awareness. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. Reason for Correction Abiomed has identified that when a patient is treated with a left ventricular Impella device and experiences an extended period (>80 minutes) with no residual pulsatility (

Early Alert: Catheter Introducer Issue from Abiomed and Oscor

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.The FDA is aware that Abiomed and its manufacturing partner Oscor have issued a letter to affected customers recommending all Introducer Kits used with Impella heart pumps be corrected prior to continued use.

Introducer Product Code
Introducer Product Description
Pump Set Product Code
GTIN
Pump Set Description

2000342
Kit, 23Fr Introducer, 11cm,   Sterile
1000323
00813502012811
Impella RP Flex with SmartAssist   Set

0052-3021
Introducer Kit, 23Fr
0046-0035
00813502011869
Impella RP Set with SmartAssist

0052-3006
Axillary Insertion Introducer
1000100
00813502012828
Impella 5.5 Set with SmartAssist

0052-3046
Kit, 14Fr Introducer, 13cm&25cm, Sterile
0048-0003
0081350201227900813502011876
Impella CP Set

Affected product sold in individual packaging:

Introducer   Product Code
Introducer Product Description
Single Sale Product Code
GTIN
Single Sale Description

2000342
Kit, 23Fr Introducer, 11cm, Sterile
1000441
00813502012910
Introducer Kit23 Fr, 11 cm

0052-3021
Introducer Kit, 23Fr
0052-0002
00813502011319
Introducer Kit 23 Fr for Impella RP

0052-3006
Axillary Insertion Introducer
0052-0011
00813502010015
Axillary Insertion Kit

0052-3046
Kit, 14Fr Introducer, 13cm&25cm, Sterile
1000550
00813502013474
Impella CP IntroducerKit 14 Fr, 13 and 25 cm

0052-3052
Kit, 14Fr Introducer, 13cm, Long Taper
0052-0038
00813502011708
Impella CP IntroducerKit 14 Fr, 13 cm

0052-3053
Kit, 14Fr Introducer, 25cm, Long Taper
0052-0039
00813502011715
Impella CP IntroducerKit 14 Fr, 25 cm

What to Do
Hospitals may continue to use existing inventory. Consider a device exchange or using the repositioning sheath to minimize blood loss if potential leakage is observed.
On June 10, 2026, Abiomed and Oscor sent all affected customers a letter recommending the following actions:

Hospitals may continue to use existing inventory. Physicians should continue to use appropriate clinical awareness, monitoring, and patient support as needed. 
Consider a device exchange or using the repositioning sheath to minimize blood loss if potential leakage from the sidearm and under the sheath cap and along the hub score lines in the hub region is observed. 
Forward the firm’s notice to anyone in your facility who manages, transports, stores, stocks, or uses the subject products
If any of the subject products have been forwarded to another facility, contact that facility and provide them with the firm’s notice.
Post a copy of the firm’s notice in a visible area for awareness.

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
Abiomed has identified a potential for introducer sheath leakage in 14Fr and 23Fr Introducers from the sidearm, under the sheath cap, and along the hub score lines in the hub region. The unexpected leakage in these locations is due to certain manufacturing issues that increase the risk of access-site bleeding. 
If this issue were to occur, the user would see blood loss at the sidearm and hub of the introducer sheath as shown below on the 14Fr introducers. Leak locations are the same for both 14Fr and 23Fr introducers.

Introducer leakage may result in access site bleeding at the time of sheath insertion or early device manipulation. This may cause blood loss requiring medical intervention, such as device exchange or removal, manual compression, and, in some cases, blood transfusion. 
In certain circumstances, particularly patients undergoing large bore vascular access with systemic anticoagulation or limited physiologic reserve (with a bleed that went undetected), exposure to this hazard may result in life-threatening hemorrhage and hemodynamic instability which may lead to death.
As of April 22, Abiomed has reported eight instances of major bleeding and three complaints that have corresponding patient deaths. Abiomed determined that the deaths are not attributable to introducer leakage.
Device Use
The Abiomed Introducer is intended to introduce catheters to the body.
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.
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.

Clover Hill Dairy Expands Recall to Include All Clover Hill Dairy Brand Cheese Due to Possible Health Risk

Source: US Department of Health and Human Services – 3

Summary

Company Announcement Date:
June 18, 2026
FDA Publish Date:
June 18, 2026
Product Type:
Food & BeveragesFoodborne Illness
Reason for Announcement:

Recall Reason Description
Potential to be contaminated with Listeria monocytogenes.

Company Name:
Clover Hill Dairy, LLC.
Brand Name:

Brand Name(s)
Clover Hill Dairy

Product Description:

Product Description
Various sizes of Hard and Soft Cheese including: Ricotta Cheese, Soft Cuajada in Brine, Soft Cuajada (vacuum sealed), Cuajada (vacuum sealed, Yummy Cheddar, White Cheddar, White Colby, Monterey Jack, Marble Jack, Fresh Cheddar Curd, Cheddar, Flavored Chee

Company Announcement
June 18, 2026 – Clover Hill Dairy of Mechanicsville, Maryland is expanding their recall to include all Clover Hill Dairy brand cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, or others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. Listeria infection can cause miscarriages and still births among pregnant women.
Clover Hill Dairy products are sold directly from their retail market, at farmers markets, and through third party distributors in North Carolina, New York, Virginia, Maryland, New Jersey and Washington, D.C. Products may be relabeled under a different brand name when distributed, including but not limited to KESSO, QUESOS LA RICURA, IZALCO, DE MI PUEBLO, RIO LINDO. Consumers are urged to check the manufacturer information on packages, if available. The label on clamshell containers should identify the Clover Hill Dairy manufacturer permit (or plant) number as “24-128”.
All Clover Hill Dairy brand cheeses currently on the market are included in this recall. Recalled products include the following:

Product Name

Quantity / Sizes

Soft Cuajada in Brine

5-gallon bucket (30-lbs), 2-gallon bucket(14-lbs)

Soft Cuajada (vacuum sealed)

5-lb bags, 2.5-lb clam shell, 0.90-lb (14-oz) clam shell

Cuajada (vacuum sealed)

30-lb boxes

Ricotta

5-gallon bucket (40-lbs), 2-gallon bucket (18-lbs), 2.5-lb tubs, 1-lb clam shell

Soft Cuajada Crumbs

 

Mild Cheese Varieties – Yummy Cheddar, White Cheddar,White Colby, Monterey Jack, Marble Jack

1/2-lb, 1-lb, 2.5-lbs, 5-lbs, 40-lbs

Mild Cheese Varieties – Snack Pack Assorted Regular MildStix White Colby, Marble Jack, Yummy Cheddar

Approx 0.40-lbs (6.4-oz)

Mild Cheese Varieties – 3-in-A-Pack Assorted White Colby,Marble Jack, Yummy Cheddar

Approx. 0.20-lbs (3.2-oz)

Mild Cheese Varieties – Fresh Cheddar Curd

0.75-lb box, 1.50-lb box

Sharp Cheese Varieties – Cheddar, Yummy Cheddar,White Cheddar, Monterey Jack

1/2-lb, 1-lb, 2.5-lbs, 5-lbs

Sharp Cheese Snack Pack Sharp Stix White or Yellow

Regular size Approx 0.40-lbs (6.4-oz)

Flavored Cheese – Horseradish

1/2-lb, 1-lb, 2.5-lb, 5-lb, 40-lb

Flavored Cheese – Old Bay Cheddar

1/2-lb, 1-lb, 2.5-lb, 5-lb, 40-lb

Pepper Jack Cheese Varieties – Jalapeno Cheddar, PepperJack, Sizzlin Colby with Habanero Peppers

1/2-lb, 1-lb, 2.5-lb, 5-lb, 40-lb

Pepper Jack Cheese Varieties – Snack Pack AssortedPepperjack Stix – Jalapeno Cheddar, Pepper Jack

Regular size Approx 0.40-lbs (6.4-oz)

Pepper Jack Cheese Varieties – 3-in-a-Pack AssortedJalapeno Cheddar, Pepper Jack, Sizzlin Colby

Approx. 0.20-lbs (3.2-oz)

Smoked Cheddar Cheese Varieties – Cheddar, White Cheddar

1/2-lb, 1-lb

Smoked Pepper Cheese Varieties – Jalapeno Cheddar

1/2-lb pieces, 1-lb pieces

To date, there have been 9 illnesses, 8 hospitalizations, and 1 death linked to the soft cheese products.
Customers should not eat, sell, or serve the recalled cheese. Please return to the point of purchase for a full refund.
Consumers with questions may contact Southern Maryland Agricultural Development Commission on behalf of Clover Hill Dairy at 240-528-8850 extension 327 Monday through Friday from 8:00am to 4:30pm eastern standard time.
Clover Hill Dairy board and staff members sincerely apologize for any inconvenience and hardships caused by this recall, and we sincerely hope to correct this problem as soon as it is safely possible. Thank you for your understanding, we look forward to serving our valued customers again in the near future.
Link to Original Press Release
Link to FDA Advisory

Company Contact Information

Consumers:
Clover Hill Dairy
240-528-8850 extension 327

Product Photos

Content current as of:
06/18/2026

Regulated Product(s)

Topic(s)

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