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Browse Device Recalls

2,527 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,527 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 2,527 FDA device recalls in IN.

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DateProductReasonClassFirm
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X40MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X35MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X55MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X30MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X45MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X35MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X55MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X40MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X60MM, Item Num... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X50MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X55MM, Item Num... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
May 5, 2020 Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X35MM, Item Nu... There are reports of inadequate locking of the extended tab screws. Complaints were reported whe... Class II Zimmer Biomet, Inc.
Apr 30, 2020 Pressure Monitoring Tray, C-PMSY, G02854 The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or in... Class II Cook Inc.
Apr 30, 2020 Centrella Smart+ Bed, Catalog Number P7900 The Bed Exit System may fail to send a remote alert through the nurse call system if a remote ale... Class II Hill-Rom, Inc.
Apr 30, 2020 Pressure Monitoring Set, C-PMS, G02838 The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or in... Class II Cook Inc.
Apr 17, 2020 Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regene... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-P... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 ... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 ... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 M... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibia... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 1... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ M... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 17, 2020 Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Const... Potential presence of elevated endotoxin levels that exceed the specification limit Class II Biomet, Inc.
Apr 15, 2020 Formula 418 Renal Balloon-Expandable Stent, RPN FOR418-18-80-6-12, Order Numb... The firm received complaints on five devices from one specific lot where the stent dislodged from... Class II Cook Inc.
Mar 13, 2020 Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model ... There were unknown bioburden levels prior to sterilization, which may affect sterility of the pro... Class II Biomet, Inc.
Mar 6, 2020 Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-... The printed expiration dates are incorrect. Class II Cook Inc.
Mar 6, 2020 Spectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Nu... The printed expiration dates are incorrect. Class II Cook Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Ite... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, It... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, S... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Ite... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, S... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 1... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, It... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Ite... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... 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.