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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.