Browse Device Recalls

162 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 162 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 162 FDA device recalls.

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DateProductReasonClassFirm
Sep 26, 2025 LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 0... Although the etched length on the screw is correct, the length marked on the external packaging i... Class II Synthes (USA) Products LLC
Sep 26, 2025 LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 0... Although the etched length on the screw is correct, the length marked on the external packaging i... Class II Synthes (USA) Products LLC
Apr 25, 2024 STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, l... Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not eng... Class II Synthes (USA) Products LLC
Jan 24, 2024 TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adult... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicl... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & acc... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation ... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing frac... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Jan 24, 2024 Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenera... Products not sterilized, sterility cannot be confirmed Class II Synthes (USA) Products LLC
Feb 1, 2023 TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intende... TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... Class II Synthes (USA) Products LLC
Feb 1, 2023 TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intende... TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... Class II Synthes (USA) Products LLC
Feb 1, 2023 TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intende... TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nail... Class II Synthes (USA) Products LLC
Sep 27, 2022 SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 The subject products are being recalled because they contain the incorrect size drill guide and w... Class II Synthes (USA) Products LLC
Sep 27, 2022 SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Us... The subject products are being recalled because they contain the incorrect size drill guide and w... Class II Synthes (USA) Products LLC
Sep 27, 2022 DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 The subject products are being recalled because they contain the incorrect size drill guide and w... Class II Synthes (USA) Products LLC
Sep 27, 2022 SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 The subject products are being recalled because they contain the incorrect size drill guide and w... Class II Synthes (USA) Products LLC
Aug 30, 2022 Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a pack... Class II Synthes (USA) Products LLC
Apr 7, 2022 Radial Head Replacement System Implant is a one-piece, stemmed radial head re... DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions f... Class II Synthes (USA) Products LLC
Dec 22, 2021 Universal Chuck-The Universal Chuck is an Instrument Handle provided as an al... Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manu... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgi... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgic... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 14.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 12.5MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 13.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 15.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Nov 19, 2020 DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgica... RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue react... Class II Synthes (USA) Products LLC
Sep 21, 2020 DePuy Synthes SYNMESH 10MM DIA 18MM HEIGHT (TI) Product Number: 495.344 - Pr... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 22MM X 28MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495-396 ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 17MM X 22MM LATERAL OR ANTERIOR/0 DEG (TI) Product Number: 495.392 ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 12MM DIA/0 DEG (TI) Product Number: 495.385 - Product Usage: is a v... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 SYNMESH 17MM X 22MM 88MM HEIGHT (TI) Product Number: 495-374 - Product Usag... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 10MM DIA/0 DEG (TI) Product Number: 495.384 - Product Usage: is a v... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 SYNMESH 15MM DIA 88MM HEIGHT (TI) Product Number: 495.366 - Product Usage: ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: ... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 3.0MM LOCKING SCREW LOW PROFILE (TI) Product Number: 495-491 - Product Usag... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC
Sep 21, 2020 END RING 15MM DIA/0 DEG (TI) Product Number: 495.386 - Product Usage: is a v... Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAG... Class III Synthes (USA) Products LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.