Recalls in December 2025 (page 3)
421 recalls.
- TS-10/TS-10H Tube Sorter recall (Sysmex America, Inc.)
Medical deviceClass IIReported January 28, 2026 · Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift. - The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique... recall (Beckman Coulter Ireland, Inc.)
Medical deviceClass IIReported January 28, 2026 · Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent... - Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog... recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported January 28, 2026 · Due to probe bags that may have a compromised or incomplete sterile pouch seal. - Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE ... recall (MicroPort Orthopedics Inc.)
Medical deviceClass IIReported January 28, 2026 · Due to products not having FDA Premarket authorization to be distributed within the United States. - Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius... recall (Tyber Medical)
Medical deviceClass IIReported January 28, 2026 · The supplier manufactured anatomical left plates with an incorrect thread orientation. - Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius... recall (Tyber Medical)
Medical deviceClass IIReported January 28, 2026 · The supplier manufactured anatomical left plates with an incorrect thread orientation. - Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b ... recall (LEASEIR TECHNOLOGIES SLU)
Medical deviceClass IIReported January 28, 2026 · The console label for affected devices is missing the "DANGER" symbol. - Allwell Angioplasty Pack REF: IS-30-B1/B recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported January 28, 2026 · Inflation device handle may detach from the syringe during procedure. - Merit Medical recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported January 28, 2026 · Inflation device handle may detach from the syringe during procedure. - Merit Medical recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported January 28, 2026 · Inflation device handle may detach from the syringe during procedure. - Merit Medical recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported January 28, 2026 · Inflation device handle may detach from the syringe during procedure. - Merit Medical recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported January 28, 2026 · Inflation device handle may detach from the syringe during procedure. - Allwell Inflation Device recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported January 28, 2026 · Inflation device handle may detach from the syringe during procedure. - Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers:... recall (Merit Medical Systems, Inc.)
Medical deviceClass IIReported January 28, 2026 · Inflation device handle may detach from the syringe during procedure. - Mazor X robotic guidance system REF: TPL0059 recall (Mazor Robotics Ltd)
Medical deviceClass IIReported January 28, 2026 · Software errors that can result in incorrect surgical instrument positioning during spinal surgery. - ICU Medical Plum Solo Precision IV Pump recall (ICU Medical, Inc.)
Medical deviceClass IIReported January 28, 2026 · Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed... - ICU Medical Plum Duo Precision IV Pump recall (ICU Medical, Inc.)
Medical deviceClass IIReported January 28, 2026 · Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed... - ICU Medical Plum Duo Infusion Pump recall (ICU Medical, Inc.)
Medical deviceClass IIReported January 28, 2026 · Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed... - Philips Azurion system recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 28, 2026 · Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized... - GE Healthcare Omni Legend recall (GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING)
Medical deviceClass IIReported January 28, 2026 · There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking... - Tego Connector: REF: 011-D1000 recall (ICU Medical, Inc.)
Medical deviceClass IIReported January 28, 2026 · Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal... - Brussel Sprouts & Kale Slaw recall (WFM Purchasing, LP)
FoodClass IReported January 21, 2026 · Undeclared Fish and Egg Allergen - Atwater's recall (One Roof LLC)
FoodClass IReported January 21, 2026 · Undeclared tree nut allergens: almonds, pecans, and walnuts. - Jumbo RAW SHRIMP recall (AZ Gems, Inc.)
FoodClass IIReported January 21, 2026 · elevated levels of chloramphenicol in frozen shrimp - Troemner Family Farm Pfeffernusse Cookies recall (Troemner Farm)
FoodClass IReported January 21, 2026 · undeclared soy, wheat, milk - Fran s PureBar Almondmilk Chocolate 46% Madagascar Plant-Based recall (Fran's Chocolates Ltd)
FoodClass IReported January 21, 2026 · undeclared hazelnut. - So Delicious Dairy Free Salted Caramel Cluster Cashewmilk recall (WhiteWave - Louisville Pilot Plant)
FoodClass IIReported January 21, 2026 · Foreign material - Ukrop's 6" Pound Cake with Buttercream Icing/Red Roses recall (Ukrop's Homestyle Foods, LLC)
FoodClass IIReported January 21, 2026 · Undeclared Soy. Label did not include soy, which was used in product. - Ukrop's 6" Pound Cake with Buttercream Icing/Pink Roses recall (Ukrop's Homestyle Foods, LLC)
FoodClass IIReported January 21, 2026 · Undeclared Soy. Label did not include soy, which was used in product. - Ukrop's 6" Pound Cake with Buttercream Icing/Confetti recall (Ukrop's Homestyle Foods, LLC)
FoodClass IIReported January 21, 2026 · Undeclared Soy. Label did not include soy, which was used in product. - Healthy Truth brand Moringa Powder recall (Organic Living Superfoods Llc)
FoodClass IReported January 21, 2026 · Products may be contaminated with Salmonella Richmond. - Publix Rice & Pigeon Peas recall (ASK Foods Inc)
FoodClass IIIReported January 21, 2026 · Undeclared Allergen (Soy) - 1972 Banana Pudding Ice Cream recall (House Of Flavors, Inc.)
FoodClass IIReported January 21, 2026 · Undeclared soy lecithin - 2248 Banana Pudding Ice Cream recall (House Of Flavors, Inc.)
FoodClass IIReported January 21, 2026 · Undeclared soy lecithin - Toothpaste: a) COLGATE recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Deodorant: a) Axe recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Petroleum jelly: a) Vaseline Petroleum Jelly recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - LUCKY ICE recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Personal Care recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Carmex a) jar recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Personal Care recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Swan recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - TUMS a) Assorted recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Halls Cough Drops a) BAGS recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - TYLENOL a) 500 MG. recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - PEPCID COMPLETE - 25CT recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - PEPTO BISMOL 32CT recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - CHILDREN NYQUIL recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - NYQUIL COLD & FLU -32CT/2PK recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - LIQUID NYQUIL a) regular recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - MOTRIN 2'S DISP.- 50CT recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - EXCEDRIN MIGRAINE 2'S- 25 CT recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - EXCEDRIN 2'S DISP.- 30 CT recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - LIQUID DAYQUIL 12/8oz recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - DAYQUIL COLD & FLU recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Claritin recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Bayer 2Pk- 25 CT recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Benadryl recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Alka Seltzer recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Aleve 1's recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Advil a) Ibuprofen recall (GOLD STAR DISTRIBUTION INC)
DrugClass IIReported January 21, 2026 · CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. - Levothyroxine Sodium Tablets recall (Alvogen, Inc)
DrugClass IIReported January 21, 2026 · Product Mix-Up: A single bottle of this lot was reported by a pharmacy to contain 88 mcg tablets instead of 150 mcg tablets. - Fluocinolone Acetonide Solution Topical Solution USP recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIIReported January 21, 2026 · Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. - Portex Spinal Tray recall (ICU Medical Inc.)
Medical deviceClass IIReported January 21, 2026 · Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to... - Pulsator Arterial Blood Sampling Kit recall (ICU Medical Inc.)
Medical deviceClass IIReported January 21, 2026 · Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to... - Abre Venous Self-Expanding Stent System recall (Medtronic Inc)
Medical deviceClass IIReported January 21, 2026 · Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in... - da Vinci SP recall (Intuitive Surgical, Inc.)
Medical deviceClass IIReported January 21, 2026 · Access Port System tray may develop cracks potentially resulting in a sterility breach. - The product is used for the evaluation of the intrinsic coagulation pathway recall (Instrumentation Laboratory)
Medical deviceClass IIReported January 21, 2026 · Potential for microbial contamination. - Plum Duo Infusion System recall (ICU Medical, Inc.)
Medical deviceClass IIReported January 21, 2026 · ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo... - ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. recall (Hologic, Inc)
Medical deviceClass IIReported January 21, 2026 · Fungal contamination of affected lot with Parengyodontium album. - Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the... recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free... - Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and... - Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and... - Medline medical procedure convenience kits labeled as: 1) ROBOTIC recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and... - Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and... - Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and... - Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS recall (Medline Industries, LP)
Medical deviceClass IIReported January 21, 2026 · Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and... - Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is... recall (Diagnostica Stago, Inc.)
Medical deviceClass IIReported January 21, 2026 · Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. - Brand Name: PALACOS Product Name: PALACOS MV pro 40 recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIReported January 21, 2026 · increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an... - Brand Name: PALACOS Product Name: PALACOS MV+G pro 40 recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIReported January 21, 2026 · increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an... - Brand Name: PALACOS Product Name: PALACOS R+G pro 40 recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIReported January 21, 2026 · increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an... - Brand Name: PALACOS Product Name: PALACOS R pro 40 recall (Heraeus Medical GmbH (Dental Division))
Medical deviceClass IIReported January 21, 2026 · increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an... - Philips Azurion Systems R3.0. Includes the following label descriptions and... recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on... - MOSAIQ Oncology Information System with Particle Therapy License recall (Elekta, Inc.)
Medical deviceClass IIReported January 21, 2026 · Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one... - Allura Xper FD20/20 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20/10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10/10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20 OR Table recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20 Biplane recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10/10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20 Biplane recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD20 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10/10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10 recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Allura Xper FD10F recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections... - Product Name: Allura Xper FD10C recall (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.)
Medical deviceClass IIReported January 21, 2026 · Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections...