These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

2,247 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
HIGHFDA DEVICE

Medline Recalls Medical Convenience Kits Over Open Seal Hazard

Medline Industries, LP recalled 1,350 medical convenience kits on December 24, 2025. The recall affects kits containing BD ChloraPrep Triple Swabsticks with potential open seals. Users should cease using these kits immediately and follow manufacturer instructions for return.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Medical Kits Due to Seal Integrity Issues

Medline Industries, LP recalled 7,570 medical convenience kits on December 24, 2025. The kits contain BD ChloraPrep Triple Swabsticks with an open seal risk. Healthcare providers and patients should stop using these kits immediately.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Intubation Tray Over High Hypoxia Risk

Medline Industries, LP recalled 130 Intubation Trays on December 24, 2025. The recalled trays may contain a smaller suction catheter that could cause respiratory failure. Patients and healthcare providers should stop using the device immediately.

Medline Industries, LP
A smaller
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HIGHFDA DEVICE

Medline Recalls Suture Removal Trays Due to Seal Failure

Medline Industries, LP recalled 2,448 Suture Removal Trays on December 24, 2025. The recall affects kits containing BD ChloraPrep Triple Swabsticks with potentially open seals. The company urges immediate cessation of use to avoid potential hazards.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Pediatric Catheter Kits Over Seal Issues

Medline Industries, LP recalled 450 pediatric catheter securement kits on December 24, 2025. The kits may contain BD ChloraPrep Triple Swabsticks with potential open seals. Users should stop using the products immediately and follow recall instructions.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Medical Kits Over Seal Defect Risk

Medline Industries, LP recalled 8,445 medical convenience kits on December 24, 2025. The kits contain BD ChloraPrep Triple Swabsticks which may have an open seal. This defect poses a high risk to patients and healthcare providers.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Sterile Resection Kits Due to Open Seal Hazard

Medline Industries, LP announced a recall of 216 kits packaged as Sterile Resection Packs on December 24, 2025. The kits contain BD ChloraPrep Triple Swabsticks that may have an open seal. The recall affects healthcare providers and patients nationwide.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Medical Kits Over Open Seal Hazard

Medline Industries, LP recalled 168 medical convenience kits on December 24, 2025. The kits may contain BD ChloraPrep Triple Swabsticks with open seals. This recall affects products distributed nationwide in the U.S.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Focalyx Technologies Recalls Software Device Over Patient Safety Risks

Focalyx Technologies issued a recall for its Focalyx Fusion software device on December 23, 2025. The device may malfunction with Windows 10, potentially causing patient harm during prostate biopsies. Users must stop using the device immediately until it is validated with Windows 11.

Focalyx Technologies
Software device
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HIGHFDA DEVICE

Beckman Coulter Sample Preparation System Recalled for Software Error

Beckman Coulter recalled 50 units of the CellMek SPS Sample Preparation System on December 23, 2025. A software error causes sample dispensation issues leading to potential sample loss and incorrect diagnoses. Healthcare providers should stop using the device immediately.

Beckman Coulter
Sample preparation
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HIGHFDA FOOD

B.C. Williams Bakery Service Recalls Cake Mix Over Milk Allergen Risk

B.C. Williams Bakery Service, Inc. recalled 95 bags of Swiss Chocolate Cake Mix on December 23, 2025, due to an undeclared milk allergen. The recall affects product model numbers 072925-220 and 071825-36 distributed nationwide. Consumers should not consume the product and should contact the company for next steps.

B.C. Williams Bakery Service
Undeclared Milk
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HIGHFDA DRUG

HANDELNINE GLOBAL Recalls Rheumacare Capsules Due to Lead Risk

HANDELNINE GLOBAL recalled Rheumacare capsules on December 22, 2025, after discovering lead contamination. The recall affects four bottles of 30 capsules each distributed in New York. Consumers should stop using the product immediately and contact their healthcare provider.

HANDELNINE GLOBAL
CGMP Deviations:
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HIGHFDA FOOD

Willy Pete's Chocolates Recalls Dark Chocolate Due to Almond Hazard

Willy Pete's Chocolates recalled 54 units of Almond Despair dark chocolate on December 22, 2025. The product contains undeclared almonds which pose a risk to consumers with nut allergies. Customers should stop using the product and seek a refund or replacement.

Willy Pete's Chocolate Company
Almonds are
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HIGHFDA DRUG

Baxter Healthcare Recalls Sterile Water for Irrigation Over Contamination

Baxter Healthcare Corporation recalled 125,496 bottles of Sterile Water for Irrigation on December 22, 2025. Plastic particles from the bottle rim contaminated the solution, posing a health risk. Consumers and healthcare providers must stop using the product immediately and seek guidance.

STERILE WATER
Presence of
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HIGHFDA DEVICE

Medline Catheters Recalled Over Infection Risk

Medline Industries recalled 228 lots of ReNewal Reprocessed Webster CS Catheters on December 22, 2025. These catheters may contain small particles that pose serious health risks, including systemic infection. Patients must stop using them immediately and follow the recall instructions.

Medline Industries, LP
These lots
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