Safety Recalls

17,560 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 4,601–4,650 of 17,560

• Medical Device Recall · December 3, 2025

  Boston Scientific Corporation

  Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;

  Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.

  Class II

• Medical Device Recall · December 3, 2025

  Philips North America

  Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. 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

• Food Recall · December 3, 2025

  McCain Foods USA Inc

  Ore-Ida Tater Tots shaped potatoes, item number OIF00215A. Frozen potato product is packaged in clear unlabeled poly bag per case. Net wt. 30 lbs. UPC 1 00 72714 00215 8. McCain Foodservice Solutions.

  Clear hard plastic fragments.

  Class II

• Medical Device Recall · December 3, 2025

  Philips North America

  Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. 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

  Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. 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 3.0T. Product Code (REF): 782145. 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 Healthcare (Suzhou) Co., Ltd.

  Philips Incisive CT

  Potential for incomplete scan due to unstable connection inside of floating sensor.

  Class II

• Medical Device Recall · December 3, 2025

  Philips North America

  Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. 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

  Medtronic Neuromodulation

  A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).

  Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.

  Class II

• Medical Device Recall · December 3, 2025

  Philips North America

  Ingenia 3.0T CX. Product Code (REF): 781271. 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

  Ingenia Ambition S. Product Code (REF): 782108. 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

• Food Recall · December 3, 2025

  Lund Food Holdings Inc

  Lunds & Byerlys Monster Cookies, Net Wt 10.0 oz (284g).. UPC 0 18169-66862 7. Lunds & Byerlys, Edina, MN 55424

  Undeclared allergens (Peanut, Egg, Soy)

  Class I

• 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

• Vehicle Recall · December 3, 2025

  Volkswagen Group of America, Inc.

  2023 VOLKSWAGEN ID.4, 2024 VOLKSWAGEN ID.4

  A vehicle fire while parked or driving can increase the risk of injury.

  Unclassified

• Food Recall · December 3, 2025

  McCain Foods USA Inc

  Sysco Imperial Potato Tater Barrel, item number 1000006067. Frozen potato product is packaged in 6/5 lb. clear unlabeled poly bags per case. UPC 1 07 34730 62740 0. Distributed by Sysco Corporation,

  Clear hard plastic fragments.

  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

• Food Recall · December 3, 2025

  Bendon Publishing

  1) Paw Patrol Heart-Shaped Gummy Candies, Mixed Fruit, Net Wt. 7 oz (200g), packaged in a cardboard box with heart-shaped top, UPC 805219643846, Distributed by Bendon, Inc. 2) Mickey Mouse Heart-Shap

  Unapproved color additive - chlorophyllin copper complex

  Class III

• Medical Device Recall · December 3, 2025

  CareFusion 303, Inc.

  BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136

  Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.

  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

  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

  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

• 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

  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

• 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: 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: 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

• 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

• 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: 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

• 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: 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

• 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: 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

  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: 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

• 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

• Vehicle Recall · December 2, 2025

  Hyundai Motor America

  2023 GENESIS G90, 2024 GENESIS G90, 2025 GENESIS G90

  Sudden, unintended braking increases 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: 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

  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: 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 · 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

  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

• Vehicle Recall · December 1, 2025

  Chrysler (FCA US, LLC)

  2025 RAM 5500, 2025 RAM 3500, 2026 RAM 3500

  An instrument panel display that does not show critical information, such as warning lights or gear selection, increases the risk of a crash.

  Unclassified

• Vehicle Recall · December 1, 2025

  KTM North America, Inc.

  2024 HUSQVARNA SVARTPILEN 401, 2025 KTM 390 ADVENTURE R, 2025 KTM 390 ENDURO R

  A loss of drive power increases the risk of a crash or injury.

  Unclassified

• Vehicle Recall · December 1, 2025

  Ford Motor Company

  2025 FORD EXPEDITION, 2025 LINCOLN NAVIGATOR

  An unexpected loss of power brake assist while driving can extend stopping distance and increase the risk of a crash. Additionally, a loss of power brake assist while ADAS features are engaged can result in the vehicle not braking as expected, increasing the risk of a crash.

  Unclassified

• Vehicle Recall · December 1, 2025

  Ford Motor Company

  2025 LINCOLN NAVIGATOR

  Inoperative or flickering reverse lights may not alert other drivers that the vehicle is reversing, increasing the risk of injury or crash.

  Unclassified

• 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

  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

  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