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Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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DateProductReasonClassFirm
Sep 22, 2017 BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g... During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core ... Class II Bard Peripheral Vascular Inc
Sep 22, 2017 Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Pr... Complain due to the hub needle came out when the nurse draw the blood and removed the tube. Class II Guangzhou Improve Medical Instruments Co., Ltd.
Sep 22, 2017 **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary ... The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass c... Class II Circulatory Technology Inc
Sep 22, 2017 VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... Class II Ortho-Clinical Diagnostics
Sep 22, 2017 Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be ... Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire func... Class II Boston Scientific Corporation
Sep 22, 2017 VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... Class II Ortho-Clinical Diagnostics
Sep 22, 2017 Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 c... Product was placed into distribution prior to completion of all required post sterilization relea... Class II Angiodynamics, Inc.
Sep 22, 2017 Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intende... Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire func... Class II Boston Scientific Corporation
Sep 21, 2017 GastriSail" Gastric Positioning Device Product Usage: The GastriSail gastr... Reports of gastric or esophageal perforation occurring in procedures where the GastriSail" Gastri... Class II Covidien LLC
Sep 21, 2017 proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System ... A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does not set the correct v... Class II Aesculap Implant Systems LLC
Sep 21, 2017 Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 006431692... There is a possibility that specific lots of catheters that have recently been distributed may be... Class III Medtronic Neuromodulation
Sep 20, 2017 Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Pe... 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these ... Class II Merit Medical Systems, Inc.
Sep 20, 2017 Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog ... 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product. Class II Merit Medical Systems, Inc.
Sep 20, 2017 Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Pe... 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these ... Class II Merit Medical Systems, Inc.
Sep 20, 2017 Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcar... Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %Do... Class III Philips Electronics North America Corporation
Sep 19, 2017 daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitiv... Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in ... Class II Intuitive Surgical, 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.
Sep 19, 2017 Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, 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 FF, Ref 208-04-74, 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 4F/4T, Beta, Ref 208-04-44, 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 AA, Ref 208-04-70, Sterile, ... 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.