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 |
|---|---|---|---|---|
| Dec 19, 2013 | Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to addres... | After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, ... | Class II | Zimmer, Inc. |
| Dec 18, 2013 | ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled ele... | Possible break in the connector of the Force Sensor. | Class II | Zimmer Biomet, Inc. |
| Dec 13, 2013 | King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King... | KLTD214 airways found inside KLTSD414 packages. The KLTSD414 airway has a lumen for use of a gas... | Class II | King Systems Corp. |
| Dec 12, 2013 | King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is inten... | On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual... | Class II | King Systems Corp. |
| Dec 10, 2013 | Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The r... | Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... | Class II | Zimmer, Inc. |
| Dec 10, 2013 | CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/poly... | Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... | Class II | Zimmer, Inc. |
| Dec 10, 2013 | Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip... | Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabec... | Class II | Zimmer, Inc. |
| Dec 9, 2013 | PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) U... | Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presen... | Class II | DePuy Orthopaedics, Inc. |
| Nov 26, 2013 | outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Sin... | Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906... | Class II | Biomet, Inc. |
| Nov 26, 2013 | G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000 | Investigation identified that the outer label, inner label, and patient label all have the incorr... | Class II | Biomet, Inc. |
| Nov 25, 2013 | MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstatio... | This issue is only relevant for customers importing xml files into the MagNA Pure 96 IVD instrume... | Class II | Roche Diagnostics Operations, Inc. |
| 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. |
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.