Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Dec 22, 2023 AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (... Filling process qualification did not demonstrate adequate process capability. Possible consequen... Class II Musculoskeletal Transplant Foundation, Inc.
Dec 22, 2023 AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010 (... Filling process qualification did not demonstrate adequate process capability. Possible consequen... Class II Musculoskeletal Transplant Foundation, Inc.
Sep 22, 2023 DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgicall... Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in ... Class II Musculoskeletal Transplant Foundation, Inc.
Mar 29, 2021 AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surg... 3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery Class II Musculoskeletal Transplant Foundation, Inc.
Aug 15, 2019 QuickGraft¿ Model # 430PST Measurement listed on the label is not taken under tension, and this would cause possible extensi... Class II Musculoskeletal Transplant Foundation, Inc.
Apr 21, 2016 Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indica... AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an... Class II Musculoskeletal Transplant Foundation, Inc.
May 27, 2015 Allofix Insertion Kit, 2.0 mm, Single Drill, Product Usage: MTF Surgical... Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits becaus... Class II Musculoskeletal Transplant Foundation, Inc.
May 27, 2015 Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do ... Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins... Class II Musculoskeletal Transplant Foundation, Inc.
Dec 4, 2014 DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone vo... The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above ma... Class II Musculoskeletal Transplant Foundation, 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.