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Browse Device Recalls

28 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 28 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 28 FDA device recalls.

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DateProductReasonClassFirm
Nov 2, 2022 Small Joint OATS Set, REF AR-8981-06S, 6mm; and Small Joint OATS Set, REF AR-... The devices may be packaged with the wrong reamer size. Class II Arthrex, Inc.
Mar 25, 2022 K-Wire, 1.35 mm x 170 mm Products do not meet length and diameter specifications. Class II Arthrex, Inc.
Jun 14, 2021 Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF... Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to t... Class II Arthrex, Inc.
Mar 11, 2021 Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use ... It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts. Class II Arthrex, Inc.
Feb 24, 2021 Drill Bit, Cannulated, 5.0 mm - Product Usage: may be used in a variety of fo... The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color. Class II Arthrex, Inc.
Jun 24, 2020 Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S -... Screws provided in packaging are 5mm shorter than intended Class II Arthrex, Inc.
Dec 17, 2019 Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instrument... There is a potential for blockage of the Hub Attachment Tube. Class II Arthrex, Inc.
Oct 1, 2019 Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-85... Screws provided in the device package are 6 mm longer than intended. Class II Arthrex, Inc.
Jan 14, 2019 Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices ar... Devices may generate excessive heat during use. Class II Arthrex, Inc.
Nov 19, 2018 Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on... Potentially lead to anchor breakage during insertion, Class II Arthrex, Inc.
Sep 13, 2018 3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibul... There is potential to break during use. Class II Arthrex, Inc.
Aug 27, 2018 Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage... The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete s... Class II Arthrex, Inc.
Oct 3, 2017 iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR ... Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 ¿UF... Class II Arthrex, Inc.
Mar 24, 2017 Anthrex SpeedBridge Implant System with PEEK SwiveLock Self Punching Some eyelets broke from SwiveLock Anchor on insertion. Class II Arthrex, Inc.
Mar 24, 2017 Anthrex Bio Composite SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching Some eyelets broke from SwiveLock Anchor on insertion. Class II Arthrex, Inc.
Mar 24, 2017 Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching Some eyelets broke from SwiveLock Anchor on insertion. Class II Arthrex, Inc.
Mar 24, 2017 Anthrex PEEK SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching Some eyelets broke from SwiveLock Anchor on insertion. Class II Arthrex, Inc.
Mar 24, 2017 Anthrex SpeedBridge Implant System with BioComposite SwiveLock SP Vented, 5.5... Some eyelets broke from SwiveLock Anchor on insertion. Class II Arthrex, Inc.
Mar 24, 2017 Anthrex Bio-SwiveLock SP Vented, 5.5mm x 24.5 mm, Self-Punching Some eyelets broke from SwiveLock Anchor on insertion. Class II Arthrex, Inc.
Aug 12, 2016 Arthrex Suture Washer The device was assembled incorrectly. Suture and washer were not assembled; components were place... Class III Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Apr 22, 2016 BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation ... Potential for polystyrene particulate presence. Class II Arthrex, Inc.
Jan 11, 2016 Arthrex Deltoid Ligament Reconstruction Implant System. Intended as a fixa... Potential for a component contained in the Implant System to be non-sterile. Class II Arthrex, Inc.
Dec 17, 2015 Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Cat... Devices reported to have a smooth texture to the outer surface of the metal, which differed from ... Class II Arthrex, 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.