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

2,324 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

GE Healthcare Omni Legend Recalled Due to Image Artifact Risk

GE Healthcare recalled 364 Omni Legend systems on December 24, 2025, after reports of image quality issues. The recall affects multiple models distributed worldwide, including the Omni Legend 16 and 21. Users should stop using the devices immediately due to potential diagnostic inaccuracies.

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
There is
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HIGHFDA FOOD

Southern Rocklobster LTD Recalls Frozen Abalone Over Listeria Risk

Southern Rocklobster LTD recalled 94 cases of frozen Australian Greenlip Abalone on December 24, 2025. The recall follows potential contamination with Listeria monocytogenes, which poses a serious health risk. Consumers should not consume the product and seek a refund.

Southern Rocklobster LTD
Potential Listeria
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HIGHFDA DEVICE

Zimmer Tourniquet Systems Recalled Due to Screen Malfunction

Zimmer Surgical Inc recalled 206 A.T.S. 5000TS Tourniquet Systems on December 24, 2025. The device can freeze or become unresponsive in certain non-English language settings. This issue may delay patient care during emergencies.

Zimmer Surgical
Device user
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HIGHFDA DEVICE

Medline Recalls Medical Kits Over Hazardous Packaging Seal

Medline Industries, LP recalled 120 medical convenience kits on December 24, 2025. The kits contain BD ChloraPrep Triple Swabsticks with potentially open seals. This recall affects products distributed nationwide in the U.S.

Medline Industries, LP
Medline Industries,
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HIGHFDA 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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HIGHFDA DEVICE

Medline Suction Catheter Kits Recalled Due to Serious Health Risk

Medline Industries, LP recalled 141,971 suction catheter kits on December 24, 2025. The kits may contain a smaller catheter that can lead to serious respiratory issues. Health providers and patients must stop using the kits immediately to prevent potential harm.

Medline Industries, LP
A smaller
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HIGHFDA DEVICE

Medline Recalls Medical Kits Over Open Seal Hazard

Medline Industries, LP recalled 21,854 medical kits on December 24, 2025, due to potential packaging defects. The recall affects kits containing BD ChloraPrep Triple Swabsticks with compromised seals. Patients and healthcare providers must stop using these kits immediately.

Medline Industries, LP
Medline Industries,
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HIGHFDA DEVICE

Medline Recalls Blood Culture Kits Due to Open Seal Hazard

Medline Industries, LP recalled 4,300 blood culture kits on December 24, 2025. The recall affects kits containing BD ChloraPrep Triple Swabsticks with packaging that may exhibit an open seal. This defect poses a high risk to patient safety.

Medline Industries, LP
Medline Industries,
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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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