Browse Device Recalls
2,560 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,560 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 2,560 FDA device recalls in IN.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 22, 2014 | Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Magna-Fx Cannulated Screw Fixation System Cannulated Bone Screw Sterile zi... | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105L... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG ... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Magna-Fx Cannulated Screw Fixation System Bone Screw Fully Threaded Sterile... | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLA... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | 6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MI... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | 6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FN... | Zimmer is recalling sterile-packaged implants and instruments packaged in six different package c... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... | Class II | Zimmer, Inc. |
| Jul 22, 2014 | 4.5 mm Malleolar Screw Sterile zimmer | Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavi... | Class II | Zimmer, Inc. |
| Jul 17, 2014 | Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8 Denta... | Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8m... | Class II | Zimmer, Inc. |
| Jul 17, 2014 | CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-... | This remedial action is the result of six product complaints associated with separation of the sn... | Class I | Cook Inc. |
| Jul 10, 2014 | Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Nu... | Zimmer received a trend of complaints indicating corrosion of product. | Class II | Zimmer, Inc. |
| Jul 10, 2014 | Natural-Knee System Patella Bushings Orthopedic surgical instrument. Part Nu... | Zimmer received a trend of complaints indicating corrosion of product. | Class II | Zimmer, Inc. |
| Jul 10, 2014 | Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part N... | Zimmer received a trend of complaints indicating corrosion of product. | Class II | Zimmer, Inc. |
| Jul 10, 2014 | Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Nu... | Zimmer received a trend of complaints indicating corrosion of product. | Class II | Zimmer, Inc. |
| Jul 1, 2014 | Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRU... | The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument ma... | Class II | Biomet, Inc. |
| Jul 1, 2014 | Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 2... | Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenest... | Class II | Zimmer, Inc. |
| Jul 1, 2014 | PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non... | The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the... | Class II | Zimmer, Inc. |
| Jul 1, 2014 | PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non... | The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the... | Class II | Zimmer, Inc. |
| Jun 26, 2014 | Esaote PA230E Transducer A portable and cart base ultrasound system for gene... | Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D... | Class II | Biosound Esaote, Inc. |
| Jun 26, 2014 | Affinity¿ Four Birthing Bed, Product Usage: Product is intended to be us... | The attachment latch mechanism can become bent depending on user handling. Latch mechanism bendi... | Class II | Hill-Rom, Inc. |
| Jun 25, 2014 | Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006 | Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant,... | Class II | Zimmer, Inc. |
| Jun 23, 2014 | Device Brand Name: Distal Radius Fracture Repair System Device Classificatio... | The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill ... | Class II | Biomet, Inc. |
| Jun 10, 2014 | Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral C... | A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an e... | Class II | Zimmer, Inc. |
| Jun 4, 2014 | ROSA Surgical Device 2.5.8 It is intended to be used in the operating ro... | Software corrections reactivating the cooperative endoscopy mode. | Class II | Zimmer Biomet, Inc. |
| Jun 3, 2014 | RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. R... | The product can be difficult to remove from the Distal Stem both out of the package and after pr... | Class II | DePuy Orthopaedics, Inc. |
| Jun 3, 2014 | RECLAIM Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manua... | The product can be difficult to remove from the Distal Stem both out of the package and after pr... | Class II | DePuy Orthopaedics, Inc. |
| Jun 3, 2014 | RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sl... | The product can be difficult to remove from the Distal Stem both out of the package and after pro... | Class II | DePuy Orthopaedics, Inc. |
| May 23, 2014 | Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESI... | Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. | Class II | Zimmer, Inc. |
| May 23, 2014 | Zimmer M/L Taper Hip Stem Standard & Extended Offset, HIP JOINT PROSTHESIS, ... | Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. | Class II | Zimmer, Inc. |
| May 23, 2014 | Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESI... | Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. | Class II | Zimmer, Inc. |
| May 21, 2014 | cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filt... | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... | Class II | Roche Diagnostics Operations, Inc. |
| May 21, 2014 | cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filt... | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... | Class II | Roche Diagnostics Operations, Inc. |
| May 21, 2014 | Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software... | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive ... | Class II | Roche Diagnostics Operations, Inc. |
| May 19, 2014 | NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... | Class II | Zimmer, Inc. |
| May 19, 2014 | NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... | Class II | Zimmer, Inc. |
| May 19, 2014 | VerSys¿ Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581 | During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-... | Class II | Zimmer, Inc. |
| May 19, 2014 | NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... | Class II | Zimmer, Inc. |
| May 19, 2014 | NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... | Class II | Zimmer, Inc. |
| May 19, 2014 | NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... | Class II | Zimmer, Inc. |
| May 19, 2014 | NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... | Class II | Zimmer, Inc. |
| May 19, 2014 | NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... | Class II | Zimmer, Inc. |
| May 19, 2014 | NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... | Class II | Zimmer, Inc. |
| May 19, 2014 | NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Compo... | Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the... | Class II | Zimmer, Inc. |
| May 15, 2014 | DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT T... | Surface finish is different than specified. The implant has 30 grit blast on the exterior of the... | Class II | Biomet, 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.