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Browse Device Recalls

1,125 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,125 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 1,125 FDA device recalls.

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DateProductReasonClassFirm
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 7, 2020 THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 ... Potential increase in fracture rate was detected during internal testing, in addition to potentia... Class II Zimmer Biomet, Inc.
Dec 23, 2019 Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00 Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed ... Class II Zimmer Biomet, Inc.
Dec 19, 2019 ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332... Potential issue associated with the instrument -end of the shaft could fail to effectively mate w... Class II Zimmer Biomet, Inc.
Dec 12, 2019 Coonrad/Morrey Total Elbow Humeral Assembly, Extra Small, 4-inch Length. Mode... The lot contained two outer pins instead of one outer and one inner pin. Class II Zimmer Biomet, Inc.
Oct 25, 2019 Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 14MM- Orthopedic ma... Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bo... Class II Zimmer Biomet, Inc.
Oct 25, 2019 Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manua... Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bo... Class II Zimmer Biomet, Inc.
Oct 10, 2019 SM DIS VOL/DORS RAD LAT COL PLATE, Item Nos. 47235801404 47235802102 472358... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 NCB Proximal Lateral Tibia, "NCB-PT LAX PROX 3H TIBIA", Various Sizes, Item N... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Custom Devices, Item Nos. 32855090246 32855090252 32855090256 3285... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Various Hip Joint Replacement Systems, Item Nos. 00151504232 00151504432 00... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Coorad Morrey Total Elbow, Item Nos. 32810502501 32810502701 32810502900 3... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer Biomet, Inc.
Oct 10, 2019 Fitmore Hip Stem, hip prosthesis, various sizes, Item Nos. 0100551102 010055... Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). Class II Zimmer 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.