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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Oct 6, 2016 | 20.2cm Heavy Duty Long Heavy Short Attachment | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | Adult Craniotome 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 30ft 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 | Electronic Foot Control with Direction or Irrigation Switches Product Usag... | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | Autolube-III with NK 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 | 22CM 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 | Foot Control, SC2100 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 | IMRI MOTOR 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 | 10.5cm QD Angle 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 | Electronic Foot Control with Direction Switch 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 | Compact Speed Reducer, 60:1 Black Max | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | eMax2 Hybrid Hand Control 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 | 11CM ANGLE ATTACHMENT, BLACK MAX | 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.