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.

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DateProductReasonClassFirm
Nov 19, 2013 NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green... This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... Class II Zimmer, Inc.
Nov 19, 2013 NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thic... This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... Class II Zimmer, Inc.
Nov 19, 2013 NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm He... This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... Class II Zimmer, Inc.
Nov 19, 2013 NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm He... This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... Class II Zimmer, Inc.
Nov 19, 2013 NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thic... This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional ins... Class II Zimmer, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 4-7 HP M.B.T. Keel P... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 2-3 HP M.B.... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 1-1.5 HP M.B.T. Keel... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED Size 4-7 HP M.B.T. K... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 1-1.5 HP M.B.T. K... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 2-3 HP M.B... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 4-7 HP M.B.T... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH NONCEMENTED Size 1-1.5 HP M.B... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT KEEL PUNCH CEMENTED SIZE 1-1.5 HP M.B.... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH CEMENTED Size 2-3 HP M.B.T. Keel P... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 2-3 HP M.B.T. Kee... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 18, 2013 SIGMA¿ LCS¿ HIGH PERFORMANCE" MBT PUNCH NONCEMENTED Size 4-7 HP M.B.T. Kee... DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Kne... Class II DePuy Orthopaedics, Inc.
Nov 12, 2013 Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6 Total a... As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial ... Class II Zimmer, Inc.
Nov 12, 2013 Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6 Total ... As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial ... Class II Zimmer, Inc.
Nov 12, 2013 Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total... As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial ... Class II Zimmer, Inc.
Nov 7, 2013 OrthoPediatrics ACL Reconstruction System is a pediatric and small stature ad... Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - Nov... Class II OrthoPediatrics Corp
Nov 5, 2013 DIST LAT FEM LOCK PLT, LT Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 ITST THREADED GUIDE PIN Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 FEM COND BUTTRESS PLT, RT. Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 TIBIO FEM/FEM NAIL. Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 TIB NAIL Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 FEM COND BUTTRESS PLT, LT Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 DIST LAT FEM LOCK PLT, RT Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 5, 2013 NGK Stem Ext 24 x 245mm Based on a review of historic packaging validations, it was determined that a subset of product p... Class II Zimmer, Inc.
Nov 4, 2013 Palacos¿ R+G Radioplaque Bone Cement 1 x 40 g Single (with Gentamicin), 40.8 ... The patient label associated with the product may be incorrect in that the lot number on the pati... Class II Zimmer, Inc.
Oct 31, 2013 NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Ti... Two complaints were received in which it was reported that the stem would not lock into the tibia... Class II Zimmer, Inc.
Oct 25, 2013 ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva C... There is a software synchronization issue with the ACCU-CHEK Combo system. In rare cases, when th... Class II Roche Diagnostics Operations, Inc.
Oct 25, 2013 REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /... Security Blades were manufactured oversized and potentially won't advance or may be difficult to ... Class II Biomet, Inc.
Oct 17, 2013 Trabecular Metal" Reverse Shoulder System As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zi... Class II Zimmer, Inc.
Oct 11, 2013 PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM ... 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 MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 4... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LA... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE L... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 FEM HD ION (various sizes) Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM a... 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 (various sizes) and 6 DEG UNIPOLAR FEMORAL HE Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 VERSYS HERITAGE FEM STEM Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUB... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500 Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB ... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... Class II Zimmer, Inc.
Oct 11, 2013 Bipolar liners and Multipolar cups with the following dimensions in MM (38, 3... Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufactur... 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.