Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

211 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 211 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 211 FDA device recalls.

Clear
DateProductReasonClassFirm
Sep 25, 2020 Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe P... The device may be incorrectly laser marked as a right stem, when it should have been laser marked... Class II Exactech, Inc.
Sep 25, 2020 Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Pl... The device may be incorrectly laser marked as a right stem, when it should have been laser marked... Class II Exactech, Inc.
Aug 24, 2020 Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm. Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it... Class II Exactech, Inc.
Aug 24, 2020 Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm. Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it... Class II Exactech, Inc.
Aug 10, 2020 The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm. The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a l... Class II Exactech, Inc.
Jan 27, 2020 Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices ar... These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The uppe... Class II Exactech, Inc.
Dec 3, 2019 Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, RE... Labels with incorrect translations were identified by Exactech is a distributor in the Netherland... Class II Exactech, Inc.
Dec 3, 2019 Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, R... Labels with incorrect translations were identified by Exactech is a distributor in the Netherland... Class II Exactech, Inc.
Oct 2, 2019 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical... Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as i... Class II Exactech, Inc.
Sep 10, 2019 Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in ... Potential for the wire to fracture at the threads and remain in the glenoid. Class II Exactech, Inc.
Jul 24, 2019 Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the im... The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn po... Class II Exactech, Inc.
Apr 26, 2019 Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45 The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to hi... Class II Exactech, Inc.
Apr 26, 2019 Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90 The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to hi... Class II Exactech, Inc.
Apr 26, 2019 Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30 The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to hi... Class II Exactech, Inc.
Mar 13, 2019 Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 ... 2.5 Truliant Fit Trays were mismarked as 3 Class II Exactech, Inc.
Dec 5, 2018 Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve ... Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Opt... Class II Exactech, Inc.
Aug 21, 2018 Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: S... The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm di... Class II Exactech, Inc.
Jul 13, 2018 Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components f... Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on t... Class II Exactech, Inc.
May 8, 2018 Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total... Potentially have non-conforming internal threads. Class II Exactech, Inc.
Oct 9, 2017 Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Co... Wrong device description of the label identifying the implant Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14,... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Ster... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12,... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Ster... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Ster... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Ster... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Ste... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX. There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, Inc.
Sep 19, 2017 Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Ster... There is a design incompatibility between certain sizes of the offset spine stiffener screw and t... Class II Exactech, 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.