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

3,615 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
Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Medical Kits Over Seal Integrity Issues

Medline Industries, LP recalled 7,380 medical convenience kits on December 24, 2025. The recall affects the PowerGlide Dressing Change Kit and Central Line Tray with ChloraPrep swabsticks. An open seal on packaging may compromise sterility and patient safety.

Medline Industries, LP
Medline Industries,
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA 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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Food & Beverages
HIGH
FDA FOOD

B.C. Williams Bakery Service Recalls Spice Cake Mix for Allergen Risk

B.C. Williams Bakery Service, Inc recalled 51 bags of Spice Cake Mix on December 23, 2025. The product contains undeclared milk allergens that pose serious health risks. Consumers should stop using the product immediately and seek refunds.

B.C. Williams Bakery Service
Undeclared Milk
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Food & Beverages
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

Medline Electrophysiology Catheters Recalled Over Infection Risk

Medline Industries recalled 41 lots of reprocessed electrophysiology catheters on December 22, 2025. These devices may contain residual material that poses serious health risks. The recall affects several specific model numbers and follows the expansion of a previous recall.

Medline Industries, LP
These lots
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Food & Beverages
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

Medline Industries Recalls Ultrasound Catheters Over Infection Risk

Medline Industries recalled 511 reprocessed AcuNav ultrasound catheters on December 22, 2025. These devices may contain small particles that can cause serious health risks such as systemic infections and embolisms. Healthcare providers must stop using the affected devices immediately to prevent potentially life-threatening complications.

Medline Industries, LP
These lots
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls St. Jude Electrophysiology Catheters Over Infection Risk

Medline Industries recalled reprocessed St. Jude electrophysiology catheters on December 22, 2025. The recall affects 48 units potentially contaminated with residual materials. The defective catheters pose a high risk of inflammation and systemic infection.

Medline Industries, LP
These lots
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Health & Personal Care
HIGH
FDA DEVICE

Medline ReNewal Catheters Recalled Due to Infection Risk

Medline Industries, LP recalled 650 ViewFlex Xtra ICE Catheters on December 22, 2025. The recall affects devices that may contain small particles of residual material. Using these catheters poses a risk of serious health complications such as systemic infection or embolism.

Medline Industries, LP
These lots
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Health & Personal Care
HIGH
FDA DRUG

DPT Laboratories Recalls Diclofenac Sodium Gel Over PH Specification Failure

DPT Laboratories recalled 92,376 tubes of Diclofenac Sodium Topical Gel, 1%, on December 22, 2025. The recall is due to the product failing pH specifications, posing a high risk to consumers. Users should stop using the gel immediately and contact healthcare providers for guidance.

DICLOFENAC SODIUM
Failed PH
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Health & Personal Care
HIGH
FDA DEVICE

Medline Industries Issues Recall of Catheters Over Infection Risk

Medline Industries recalled 94 lots of Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters on December 22, 2025. The catheters may contain small particles that pose a risk of serious health issues. Users should stop using the devices immediately and follow manufacturer instructions for return.

Medline Industries, LP
These lots
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Health & Personal Care
HIGH
FDA 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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Health & Personal Care
HIGH
FDA DEVICE

Philips North America Issues Recall for Patient Information Center Software

Philips North America recalled 146 units of Patient Information Center software on December 22, 2025. A software patch modifies Mobile Event Notification filter settings without notifying users. The recall affects units distributed worldwide, including 41 in the U.S.

Philips North America
A recent
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