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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Device Recalls

1,516 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,516 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 1,516 FDA device recalls in FL.

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DateProductReasonClassFirm
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.
Aug 31, 2017 Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulde... Potentially mislabeled. Class II Exactech, Inc.
Aug 31, 2017 Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder... Potentially mislabeled. Class II Exactech, Inc.
Aug 18, 2017 Xper Flex Cardio Physiomonitoring system. Used to facilitate invasive inve... Intermittent communication between the host system and the FlexCardio Class II Invivo Corporation
Aug 11, 2017 Xper Flex Cardio PhysioMonitoring system The Xper Flex Cardio physiomonitor... Intermittent communication between the host system and the Flex Cardio Class II Invivo Corporation
Aug 7, 2017 Total Hip Application (THA) Product Usage: The Robotic Arm Interactive O... Software discrepancy of not showing all the EE constants, when the screen is filled. Class II Mako Surgical Corporation
Aug 7, 2017 Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm ... Software discrepancy of not showing all the EE constants, when the screen is filled. Class II Mako Surgical Corporation
Jul 19, 2017 GENICON EZEE Retrieval, sterile, Rx only. Plastic handle is breaking off of shaft inhibiting proper removal per Instructions for Use. Class II Genicon, Inc.
Jul 11, 2017 Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool Vix Bit may fracture during use. Class II Exactech, Inc.
Jun 23, 2017 Truliant Tibial Trial Handle. To assist the surgeon in the implantation of... The Truliant Tibial Trial Handle's pin may disassociate from the main body. Class II Exactech, Inc.
Jun 7, 2017 MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to ... An intermittent electrical problem that could lead to a loss of system power due to a loose screw... Class II Mako Surgical Corporation
May 31, 2017 SoftLab Software Laboratory information system to be used in a medical res... Display of lab results based on incorrect LOINC code/test descriptions for tests that were perfor... Class II Soft Computer Consultants, Inc.
May 25, 2017 Logic Fit Tibial Tamp Head The firm determined that the labeling (surgical technique) should be updated to clarify the prope... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-2... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01 Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Cat... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 25, 2017 EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: ... Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream... Class II Exactech, Inc.
May 22, 2017 Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in th... The firm determined that the labeling (surgical technique) should be updated to clarify the prope... Class II Exactech, Inc.
May 16, 2017 Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactec... Possible inner labeling and packaged device not matching the outer label on the box. Class II Exactech, Inc.
May 16, 2017 Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exacte... Possible inner labeling and packaged device not matching the outer label on the box. Class II Exactech, Inc.
Apr 21, 2017 Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymat... May result in elevated platelet backgrounds during routine startup/background checks. Class II JAS Diagnostics Inc.
Apr 11, 2017 Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 Part of the number on the tray lid differ from the part number on the base. Class II Biomet Microfixation, LLC
Apr 7, 2017 Exactech Optetrak Logic CC 15mm Tibial Augment Screws Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged ... Class II Exactech, Inc.
Apr 5, 2017 SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the foldi... Complaints concerning kinked haptics that were occurring during lens delivery. Class II Bausch & Lomb Surgical, Inc.
Mar 31, 2017 ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ... The Reusable Oscor ATAR extension cables could separate from the connector during use. Class I Oscor, Inc.
Mar 31, 2017 ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Seri... The Reusable Oscor ATAR extension cables could separate from the connector during use. Class I Oscor, Inc.
Mar 24, 2017 Legacy Base for Dual Bed Configurations A potential for dual-configured beds to separate or slip away from one another. Class II Craftmatic Industries, 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 Craftmatic Model 1 Base for Dual Bed Configurations A potential for dual-configured beds to separate or slip away from one another. Class II Craftmatic Industries, 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.
Mar 23, 2017 Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column a... Elevating Monitor Suspension column dropping and will not rise back up. Class II Omega Medical Imaging, Inc.
Mar 10, 2017 HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Prod... In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to th... Class I Heartware
Mar 8, 2017 BIOMET 3i LTX DENTAL IMPLANTS Model LTX610 (6x10mm) - Plastic tray within ... A single lot of product that potentially has a single part within the lot that does not match the... Class II Biomet 3i, LLC

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.