Browse Device Recalls
2,549 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,549 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 2,549 FDA device recalls in IN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 11, 2013 | 12/14 COCR FEMORAL HEAD (2, 3 and 4); 12/14 FEMORAL HEAD (+7X28M and 7X32M) | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes s... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM P... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE P... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900. | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | 6 DEGREE COCR FEM HEAD 36 | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | HGP II ACETABULAR CUP BON | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | HGP II ACETABULAR CUP MOD | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN) | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. ... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541,... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes) | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | ASIA ONE-PIECE LAG SCREW | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | ZIMTRON 6 DEG 22 HEADS | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIU... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | 3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE ... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item co... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, ... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 00... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | CPT 12/14 COCR (various sizes) | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENE... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | 3.5 X 10 CORT SCREW SELFT 3.5 X 12 CORT SCREW SELFT 3.5 X 14 CORT SCREW SEL... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | PRESSFIT FEM ST FX 16 X 1 | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | 1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRU... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 11, 2013 | 2.7 X 6 CORT SCREW/SELFTA 2.7 X 7 CORT SCREW/SELFTA 2.7 X 8 CORT SCREW/SELF... | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... | Class II | Zimmer, Inc. |
| Oct 10, 2013 | Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usa... | Investigation identified that the design of the drill bit may make the suture anchor difficult to... | Class II | Biomet, Inc. |
| Oct 9, 2013 | Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, ... | Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.... | Class II | Zimmer, Inc. |
| Sep 26, 2013 | 3.5MM LOCKING SCREW, T15 HEXALOBE, SELF TAPPING, 34MM The OrthoPediatrics ... | The firm identified, through complaints that the 3.5MM LOCKING SCREW packaging material was marke... | Class II | OrthoPediatrics Corp |
| Sep 16, 2013 | SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiot... | The SmartSet¿ GMV Endurance Gentamicin Bone Cement, product ref: number 3105-040 is intended for ... | Class II | DePuy Orthopaedics, Inc. |
| Sep 16, 2013 | COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers ... | Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service A... | Class II | Roche Diagnostics Operations, Inc. |
| Sep 3, 2013 | King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult... | Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to ... | Class III | King Systems Corp. |
| Aug 30, 2013 | Natural-Knee¿ II Femoral Component | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Versys¿ Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEA... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Sidus" Head (Not distributed in the United States) | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOA... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Gender Solutions" Patello-Femoral Component | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | NexGen¿ Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated i... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Zimmer¿ Unicompartmental Knee Femoral Component. Indicated for patients wi... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Metasul¿ Head. Intended for use either with or without bone cement in tota... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the Unit... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | CoCr Head (Not distributed in the United States) Used in total hip replace... | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 30, 2013 | Natural-Knee¿ Flex Femoral Component. Provides increased flexion capability. | The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished s... | Class II | Zimmer, Inc. |
| Aug 28, 2013 | C2244.3808, CONELOG Titanium Base CC ¿3.8GH0.8 inkl HS Product Usage: End... | Product not cleared for sale/use in the United States. | Class II | Camlog Usa |
| Aug 28, 2013 | C2244.3820;, CONELOG Titanium Base CC ¿3.8GH2.0 inkl HS Product Usage: En... | Product not cleared for sale/use in the United States. | Class II | Camlog Usa |
| Aug 28, 2013 | VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Herit... | Based on a review of historic packaging validations, it was determined that a subset of product p... | Class II | Zimmer, Inc. |
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.