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
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.
Oct 19, 2016 Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile ... Products are not designed, qualified, manufactured, and/or managed under a state of control per i... Class II Ultroid Technologies, Inc.
Oct 19, 2016 Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes. Products are not designed, qualified, manufactured, and/or managed under a state of control per i... Class II Ultroid Technologies, Inc.
Oct 19, 2016 Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit includin... Products are not designed, qualified, manufactured, and/or managed under a state of control per i... Class II Ultroid Technologies, Inc.
Oct 6, 2016 Autolube-III Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 PEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Bearing Sleeve, 10CM Curved Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 5.9CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 IMRI SHORT HD ATTACHMENT Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 8.0cm Medium Attachment Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Otologic Curved Micro Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 6.5CM ADLT CRANI, THIN FT PLATE Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Bearing Sleeve, 15CM Straight Taper Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 16cm Minimally Invasive Attachment Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Minimal Access Attachment Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Minimal Access Attachment, BLACK MAX Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Sagittal Saw Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 19CM ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Console, eMax2 Plus Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Chuck Driver System Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 SMALL ATTACHMENT, JACOBS CHUCK Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Minimal Access Straight Driver Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 B-SAGITTAL ASSEMBLY Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 7.2cm Adjustable Drill Guide Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 8CM ANGLE ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 11.25CM ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 10.5CM ANGLE ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 KEYLESS DRIVER, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 LARGE CRANIOTOME, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 16.5CM MICRO REVISION ATTACH, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Oscillating MICRO-SAW Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 14cm QD Angle Attachment Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Pediatric Craniotome Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 XMAX Motor (Pneumatic Drill System) Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 Sagittal MICRO-SAW Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, Inc.
Oct 6, 2016 5.0cm Heavy Duty Short Attachment Supplied Directions for Use (DFU) did not contain a recommended service interval. Class II The Anspach Effort, 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.