fda regulated Recalls

689 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DEVICE

Fujirebio Diagnostics Recalls Diagnostic Test Over Inaccurate Results

Fujirebio Diagnostics recalled 23 units of its Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio test on December 11, 2025. The recall follows concerns that the product may produce inaccurate test results, potentially misclassifying patients with Alzheimer's disease. Healthcare providers should stop using this device immediately and follow recall instructions.

Fujirebio Diagnostics
Customers may
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Health & Personal Care
HIGH
FDA DEVICE

Applied Medical Resources Recalls Cannula Due to Blade Hazard

Applied Medical Resources recalled 450 units of the Kii Low Profile, Bladed Dual Pack on December 11, 2025, due to a potential safety issue. The blade obturator may extend beyond safe limits after assembly, posing a risk to patients. Healthcare providers and patients should stop using the device immediately.

Applied Medical Resources
There is
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Food & Beverages
HIGH
FDA FOOD

White Castle Original Sliders Recalled Due to Undeclared Allergens

White Castle recalled 1,021 cases of Original Sliders on December 10, 2025. The product contains undeclared milk and soy allergens, posing a high risk to consumers. The affected lot codes are 9H203521 and 9H203522, with a Best By date of April 18, 2026.

White Castle System
Undeclared allergens
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical Recalls 2,095 da Vinci S, Si EndoWrist Tenaculum Forceps Instrument (2025)

Intuitive Surgical recalled 2,095 units of the da Vinci S, Si EndoWrist Tenaculum Forceps Instrument distributed nationwide in the United States and in multiple countries after reports of frayed or broken pitch cables. The defect can compromise instrument control during surgery. Hospitals and surgeons should stop using the device immediately and follow recall instructions from Intuitive Surgical.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical da Vinci S, Si Grasping Retractor Instrument Recalled for 2,660 Units (2026)

Intuitive Surgical recalled 2,660 da Vinci S/Si Grasping Retractor Instruments worldwide after increased complaints of broken or frayed grip cables. The devices transmit motion from input disks to the distal tip and are used in robotic surgery. Hospitals and surgical centers should stop using the device immediately and follow recall instructions from the manufacturer.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical da Vinci S/Si Mega Needle Driver Instrument Recall 7,819 Units Worldwide (2026)

Intuitive Surgical recalled 7,819 units of the da Vinci S/Si Mega Needle Driver Instrument sold worldwide to hospitals and healthcare providers. The recall cites broken or frayed grip cables that can impair instrument control. Stop using the device and follow the manufacturer’s recall instructions for replacement or service.

Intuitive Surgical
Due to
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Health & Personal Care
HIGH
FDA DEVICE

Intuitive Surgical da Vinci S/Si EndoWrist Recall 6,152 Instruments for Pitch Cable Frays (2026)

Intuitive Surgical recalled 6,152 da Vinci S, Si Permanent Cautery Hook Instruments distributed to U.S. hospitals and clinics overseas. The defect involves frayed or broken pitch cables. Healthcare facilities should stop using the instruments immediately and follow manufacturer recall instructions. If you operate with these tools, consult your supplier or Intuitive Surgical for next steps.

Intuitive Surgical
Due to
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Food & Beverages
HIGH
FDA FOOD

Goldenroot Ginger Beer Recalled Over Pasteurization Issues

Goldenroot recalled 1,066 cases of Lemon Ginger Elderberry Ginger Beer on December 8, 2025. The product may contain unpasteurized ginger juice, posing a health risk. Consumers should stop using the product immediately and seek a refund or replacement.

Weaver's Brew
Ginger Beer
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Food & Beverages
HIGH
FDA FOOD

Goldenroot Ginger Beer Recalled Over Pasteurization Issues

Goldenroot recalled 649 cases of Yuzu Ginger Lemongrass Ginger Beer on December 8, 2025. The product may contain ginger juice that did not undergo required pasteurization. Consumers should not consume it and seek refunds from Weaver's Brew LLC.

Weaver's Brew
Ginger Beer
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Health & Personal Care
HIGH
FDA DEVICE

Philips Azurion Systems Recalled Due to Software Issues

Philips recalled 990 Azurion Systems on December 8, 2025, after nine software issues were identified. The defects may cause loss of X-ray functionality, system restarts, and other operational failures. Healthcare providers must stop using the devices immediately.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Nine (9)
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Food & Beverages
HIGH
FDA FOOD

Fresh & Ready Foods Recalls Tacos Due to Foreign Material Hazard

Fresh & Ready Foods recalled 62 units of Spicy Egg Potatoes Cheese Tacos on December 5, 2025. The product may contain foreign material posing a health risk. Consumers should not eat the tacos and seek refunds immediately.

Fresh & Ready Foods
Foreign material.
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Food & Beverages
HIGH
FDA FOOD

Fresh & Ready Foods Recalls Breakfast Burrito Over Foreign Material

Fresh & Ready Foods recalled 278 units of Spicy Veggie Breakfast Burrito on December 5, 2025. The recall occurred due to foreign material found in the product. Consumers should not eat the burrito and should seek a refund or replacement.

Fresh & Ready Foods
Foreign material.
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Health & Personal Care
HIGH
FDA DEVICE

Merit Medical Recalls Custom Procedure Kits Due to Detachment Hazard

Merit Medical Systems recalled multiple Custom Procedure Kits on December 4, 2025, due to a risk of the inflation device handle detaching from the syringe during use. The recall affects several reference numbers sold worldwide, including in the U.S. and various international markets.

Merit Medical Systems
Inflation device
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Health & Personal Care
HIGH
FDA DEVICE

Philips Recalls Ingenia Elition S MR Systems Over Stiffness Errors

Philips North America recalled five Ingenia Elition S MR systems on December 3, 2025. The recall affects systems with software versions R11.1 and R12.1 due to potential errors in stiffness value readings. This issue poses a serious risk to patient safety when interpreting MR Elastography maps.

Philips North America
The potential
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Health & Personal Care
HIGH
FDA DEVICE

Zimmer Recalls Affixus Femoral Nails Over Fracture Risk

Zimmer Inc. recalled 24 units of Affixus Antegrade Femoral Nails on December 2, 2025. The recall follows reports of undersized distal diameters that could lead to implant fatigue fractures. This defect poses a high risk of adverse tissue reactions and requires immediate action.

Zimmer
Affected implants
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Health & Personal Care
HIGH
FDA DEVICE

Zimmer Recalls Affixus Femoral Nails Due to Fracture Risk

Zimmer, Inc. recalled 11 units of the Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have an undersized distal diameter, posing a risk of fatigue fracture. This defect could cause adverse reactions requiring surgical intervention.

Zimmer
Affected implants
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Health & Personal Care
HIGH
FDA DEVICE

BD Catheter Recalled Due to Incorrect Expiration Labeling

BD recalled 149,310 hydrophilic catheters due to a labeling error regarding expiration dates. The recall affects the 14 Fr (4.7 mm) straight tip model, REF: RTU14F. Healthcare providers and patients must stop using the product immediately.

HANGZHOU BEVER MEDICAL DEVICES CO.
Labeling error,
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Health & Personal Care
HIGH
FDA DEVICE

RaySearch Laboratories Recalls Radiation Therapy Software Due to Dose Calculation Error

RaySearch Laboratories AB recalled its RayStation/RayPlan software on November 28, 2025, due to potential inaccuracies in radiation dose calculations. The issue affects certain Regions of Interest (ROIs) and could lead to incorrect treatment planning. Healthcare providers and patients should stop using the software immediately.

RAYSEARCH LABORATORIES AB
Potential for
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Tag Statistics

Total Recalls
689

Related Tags

immediate actionchemical hazardadult productelectrical hazardstop use immediatelyreturn for refundcpsc regulatedpoisoning risksuffocation risklaceration riskrepair availablereplacement available