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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.