1,319 recalls tagged with “fda regulated”.
Fujirebio Diagnostics recalled 1,569 units of Lumipulse G pTau 217 Plasma Immunoreaction Cartridges on December 11, 2025. The recall affects users due to potential inaccurate test results associated with Alzheimer's disease classifications. Customers in 13 states should stop using the product immediately.
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.
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 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 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 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 recalled 2,370 units of the da Vinci S, Si Double Fenestrated Grasper Instrument distributed worldwide on December 9, 2025. The EndoWrist instruments use mechanical cables to transmit motion. Healthcare facilities should stop using the devices and follow the manufacturer’s recall instructions.
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 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.
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.
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 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 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.
HydroJug recalls its 14-ounce children’s sport tumbler sold through HydroJug's online store after reports of a choking hazard. The rivet-attached handle can loosen and detach from the lid, posing a choking risk to children. Stop using the tumbler and contact HydroJug at service@thehydrojug.com for a free replacement lid.
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.
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, 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 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 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.
Advanced Bionics recalled 2 Sky CI M90 behind-the-ear sound processors on 2025-11-27. The packaging label does not match the included product. Consumers should stop using the device and follow manufacturer instructions.