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Browse Device Recalls

37 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 37 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 37 FDA device recalls.

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DateProductReasonClassFirm
Sep 9, 2025 BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HE... Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... Class II BioPro, Inc.
Sep 9, 2025 BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10... Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... Class II BioPro, Inc.
Sep 9, 2025 BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT ... Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... Class II BioPro, Inc.
Sep 9, 2025 BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERA... Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... Class II BioPro, Inc.
Sep 9, 2025 BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic he... Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... Class II BioPro, Inc.
Sep 9, 2025 BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131... Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 17036 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MS, Part ID 17198 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 16815 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 17035 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC LG, Part ID 17038 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 16813 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 17197 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 16816 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 16814 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Feb 1, 2022 Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037 There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU... Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x85, Item Number 19665 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x110, Item Number 19670 - Product Usage:Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Single Trocar 1.1x150mm, Item Number OL15011S - Product Usage: Accesso... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x90, Item Number 19666 - Product Usage:Accessories to the BioP... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x115, Item Number 19671 - Product Usage: Accessories to the Bi... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Sterile Single Trochar, Item Number 19106 - Product Usage: Accessories... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire HBS Sterile Lot, Item Number 19688 - Product Usage: Accessories to the... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x105, Item Number 19669 - Product Usage: Accessories to the Bi... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x36, Item Number 19654 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Single Trocar 2.5x170mm, Item Number OL17025S - Product Usage: Accesso... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x100, Item Number 19668 - Product Usage: Accessories to the Bi... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x30, Item Number 19651 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire HBS Sterile, Item Number 19688 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Sterile Single Trochar .045, Item Number 19108 - Product Usage: Access... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Single Trocar 1.6x150mm, Item Number OL15016S - Product Usage: Accesso... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x38, Item Number 19655 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x95, Item Number 19667 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x34, Item Number 19653 - Product Usage: Accessories to the Bio... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 K-Wire Single Trocar 2.5x150mm, Item Number OL15025S - Product Usage: Accesso... Manufacturing flaw in the sterile barrier system Class II BioPro, Inc.
Jun 25, 2019 Go-EZ Screw 6.5x120, Item Number 19672 - Product Usage: Accessories to the Bi... Manufacturing flaw in the sterile barrier system Class II BioPro, 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.