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Browse Device Recalls

1,515 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,515 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 1,515 FDA device recalls.

Clear
DateProductReasonClassFirm
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.
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.
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.
Feb 26, 2020 BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Ite... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 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, 64 MM, Silicone, Sterile,... Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning... Class II Biomet, Inc.
Feb 26, 2020 BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 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 w/Reinforcement, 17 X 165 MM, 64 MM, ... 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 Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, It... 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, 9... 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 14 MM, 58 X 24 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 w/Reinforcement, 13 X 145 MM, 57 MM, ... 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, 48 MM, Silicone, Sterile,... 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 Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, It... 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 25, 2020 Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper A... Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may ... Class II Biomet, Inc.
Feb 17, 2020 Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Prod... A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. Class II Biomet, Inc.
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Refe... Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... Class II Biomet 3i, LLC
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Refere... Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... Class II Biomet 3i, LLC
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Refere... Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... Class II Biomet 3i, LLC
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 4MM(H) ... Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... Class II Biomet 3i, LLC
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 7.5MM(P) X 4MM(H) Reference... Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... Class II Biomet 3i, LLC
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 3MM(H) Referen... Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... Class II Biomet 3i, LLC
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 4MM(H) Referen... Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... Class II Biomet 3i, LLC
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Refer... Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... Class II Biomet 3i, LLC
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Referen... Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... Class II Biomet 3i, LLC
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Referen... Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... Class II Biomet 3i, LLC
Jan 10, 2020 CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H) Refe... Resulting impression or scanned data produced from the Healing Abutment lots will result in an in... Class II Biomet 3i, LLC

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.