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Browse Device Recalls

1,503 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,503 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 1,503 FDA device recalls in FL.

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DateProductReasonClassFirm
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
Feb 23, 2017 Ziehm Imaging solo FD Mobile Fluoroscopic C-arm During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel wa... Class II Ziehm Imaging Inc
Feb 16, 2017 Cordis S.M.A.R.T. Flex Vascular Stent System Deployment Difficulty. Class II Cordis Corporation
Feb 3, 2017 HeartWare HVAD System Controller The HeartWare Ventricular Assist System (V... Product recall of all HVAD Controllers currently on the market and to exchange them for the next... Class I Heartware
Jan 23, 2017 RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound.... Incorrect instructions for use (IFU) included. Class II RTI Surgical, Inc.
Jan 14, 2017 MEDHOT MTI 2000 THERMAL IMAGING SYSTEM - TotalVision software with Elevated B... Indications for use are not cleared or approved for market in the U.S. Class II Med-Hot Thermal Imaging, Inc.
Dec 22, 2016 MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic ... Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides Class II Mako Surgical Corporation
Nov 11, 2016 Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Inte... Lack of 510k clearance for design modification. Class II Smith & Nephew, Inc.
Nov 11, 2016 Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Sup... Lack of 510k clearance for design modification. Class II Smith & Nephew, Inc.
Nov 7, 2016 Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte,... Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies ... Class II Exactech, Inc.
Nov 7, 2016 Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6 Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies ... Class II Exactech, Inc.
Nov 7, 2016 AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +... Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies ... Class II Exactech, Inc.
Oct 25, 2016 Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver. Class II Exactech, Inc.
Oct 19, 2016 Ultroid Sterile Disposable Probes sold individually Products are not designed, qualified, manufactured, and/or managed under a state of control per i... Class II Ultroid Technologies, 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.