Safety Recalls

15,186 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 3,051–3,100 of 15,186

• Medical Device Recall · December 3, 2025

  Philips North America

  MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.

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

  Class II

• Medical Device Recall · December 3, 2025

  Philips North America

  Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.

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

  Class II

• Medical Device Recall · December 3, 2025

  Philips North America

  SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.

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

  Class II

• Medical Device Recall · December 3, 2025

  Philips North America

  Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.

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

  Class II

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Food Recall · December 2, 2025

  Mellace Family Brands California Inc

  1) Wegmans Deluxe Mixed Nuts, Unsalted, Net Wt. 34 oz. (964g), packaged in a plastic tub with UPC 077890421314, packed 6 tubs per case 2) Wegmans Deluxe Mixed Nuts, Unsalted, Net Wt. 11.5 oz. (326g),

  Potential contamination with Salmonella

  Class I

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Medical Device Recall · December 2, 2025

  Microbiologics Inc

  LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L

  Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

  Class II

• Vehicle Recall · December 2, 2025

  Volkswagen Group of America, Inc.

  2025 VOLKSWAGEN ATLAS, 2025 VOLKSWAGEN ATLAS CROSS SPORT

  A sudden loss of drive power can increase the risk of a crash.

  Unclassified

• Medical Device Recall · December 2, 2025

  Microbiologics Inc

  KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P

  Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

  Class II

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Vehicle Recall · December 2, 2025

  Volkswagen Group of America, Inc.

  2023 VOLKSWAGEN ARTEON, 2023 VOLKSWAGEN TIGUAN, 2024 AUDI Q3, 2024 VOLKSWAGEN TIGUAN, 2025 AUDI Q3

  A rearview camera that does not display an image can reduce the driver's rear view, increasing the risk of a crash.

  Unclassified

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Vehicle Recall · December 2, 2025

  Volkswagen Group of America, Inc.

  2023 AUDI Q5, 2024 AUDI Q5

  A high-voltage battery that overheats increases the risk of a fire.

  Unclassified

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Food Recall · December 2, 2025

  Lily's Bakery Factory

  Cuban Crackers Galletas Cubanas, Net Wt 8Oz (226g). Distributed by Best Floridian, LLC. UPC 5700300060

  Undeclared colors FD&C yellow #5, FD&C yellow #6, and FD&C red 40

  Class II

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Food Recall · December 2, 2025

  Fazt & Loud LLC

  Lost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged

  Recall is due to a misprint on the label that incorrectly identifies the total caffeine content on the can. The item contains 300mg of caffeine, instead of 150mg as provided on the can.

  Class III

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Medical Device Recall · December 2, 2025

  Microbiologics Inc

  KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K

  Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

  Class II

• Medical Device Recall · December 2, 2025

  Zimmer, Inc.

  Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 m

  Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

  Class II

• Medical Device Recall · November 29, 2025

  HANGZHOU BEVER MEDICAL DEVICES CO., LTD.

  BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F

  Labeling error, Incorrect expiration date

  Class II

• Medical Device Recall · November 28, 2025

  RAYSEARCH LABORATORIES AB

  RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System

  Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

  Class II

• Medical Device Recall · November 28, 2025

  RAYSEARCH LABORATORIES AB

  Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Componen

  Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

  Class II

• Medical Device Recall · November 28, 2025

  RAYSEARCH LABORATORIES AB

  Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component:

  Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

  Class II

• Medical Device Recall · November 28, 2025

  RAYSEARCH LABORATORIES AB

  RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1.

  Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

  Class II

• Medical Device Recall · November 28, 2025

  RAYSEARCH LABORATORIES AB

  Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product De

  Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

  Class II

• Medical Device Recall · November 28, 2025

  RAYSEARCH LABORATORIES AB

  Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatme

  Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

  Class II

• Medical Device Recall · November 28, 2025

  RAYSEARCH LABORATORIES AB

  Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description:

  Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

  Class II

• Medical Device Recall · November 28, 2025

  RAYSEARCH LABORATORIES AB

  Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Tre

  Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

  Class II

• Food Recall · November 28, 2025

  Mondelez Global Llc

  Ritz Peanut Butter Cracker Sandwiches, Net Wt. 27.6 oz.- 20 Count (20 x 1.38-oz. 6-pack carton)

  Undeclared allergens (Peanut) due to mispackaging

  Class II

• Medical Device Recall · November 28, 2025

  RAYSEARCH LABORATORIES AB

  RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatmen

  Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

  Class II

• Medical Device Recall · November 28, 2025

  Baxter Healthcare Corporation

  SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

  Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on the cam, which could lead to premature wear of the mechanism assembly, resulting in over-infusion or a free-flow situation.

  Class II

• Medical Device Recall · November 27, 2025

  Advanced Bionics, LLC

  Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150

  Behind-the-ear sound processer packaging label is different then included product.

  Class II

• Medical Device Recall · November 26, 2025

  Medline Industries, LP

  Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WE

  Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.

  Class II

• Drug Recall · November 26, 2025

  Golden State Medical Supply Inc.

  Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only, Marketed by: GSMS, Incorporated, CA 93012 USA. NDC 51407-973-10

  Presence of Foreign Tablets/Capsules

  Class II

• Consumer Product Recall · November 26, 2025

  Hubei Suishanghui E-commerce Co., Ltd. dba Ikuso, of China

  Ikuso Safety Gates

  The recalled gates violate the mandatory standard for expansion gates and expandable enclosures because a child's torso can fit through the opening between the gate slat and the side wall, posing a risk of serious injury or death due to entrapment.

  Unclassified

• Consumer Product Recall · November 26, 2025

  NingBoMaiHuangHuWaiYongPinYouXianGongSi, dba Winkids, of China

  Alinux Baby Loungers

  The recalled baby loungers violate the mandatory safety standard for Infant Sleep Products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury to infants.

  Unclassified

• Consumer Product Recall · November 26, 2025

  Ji Nan BinCai E-Commerce Co., Ltd. dba Ebern Designs, of China

  Ebern Designs Ojaswi 12-Drawer Dressers

  The recalled dressers are unstable if they are not anchored to the wall, posing tip-over and entrapment hazards that can result in serious injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.

  Unclassified

• Consumer Product Recall · November 26, 2025

  Shenzhen Bosen Trading Co., Ltd., dba Bosen US, of China

  Sofoliana and Glotika Baby Loungers

  The recalled baby loungers violate the mandatory safety standard for Infant Sleep Products. The sides are too low to contain an infant and the enclosed openings at the foot of the loungers are wider than allowed, posing serious risks of fall and entrapment hazards to infants. In addition, the baby loungers do not have a stand, posing a fall hazard if used on elevated surfaces. These violations create an unsafe sleeping environment and can cause death or serious injury.

  Unclassified

• Medical Device Recall · November 26, 2025

  Cook Incorporated

  Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-

  Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.

  Class II