fda regulated Recalls

Fujirebio Diagnostics Recalled pTau 217 Plasma Cartridges

Fujirebio Diagnostics Recalls Diagnostic Test Over Inaccurate Results

Applied Medical Resources Recalls Cannula Due to Blade Hazard

There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.

Ukrop's Pound Cake Recalled Due to Undeclared Soy Allergen

Ukrop's Homestyle Foods recalled 61 units of its 6" Pound Cake on December 11, 2025. The product contains undeclared soy, posing a risk to those with soy allergies. The cakes were distributed to Virginia and West Virginia.

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.

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

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

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

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Intuitive Surgical recalls 2,370 da Vinci S/Si Double Fenestrated Grasper Instruments (2026)

Due to increased complaints for broken/frayed grip cables for reusable instruments.

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

Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments

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

Due to increased complaints for broken/frayed grip cables for reusable instruments.

Philips Azurion Systems Recalled Due to Software Issues

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 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.

Merit Medical Recalls Custom Procedure Kits Due to Detachment Hazard

Inflation device handle may detach from the syringe during procedure.

HydroJug Recalls 14-Ounce Children’s Sport Tumblers for Choking Hazard (2025)

Philips Recalls Ingenia Elition S MR Systems Over Stiffness Errors

The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).

Zimmer Recalls Affixus Femoral Nails Over Fracture Risk

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.

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.

RaySearch Laboratories Recalls Radiation Therapy Software Due to Dose Calculation Error