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 |
|---|---|---|---|---|
| Oct 6, 2016 | Foot control irrigation 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 | 90 degree Contra 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 | IMRI SHORT 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 | Bearing Sleeve, 15CM Straight 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 | BLACKMAX-NEURO LOW PRESSURE 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 | Rotating Large Craniotome | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | System Console, Single Port, with irrigation 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 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 | STANDARD CRANIOTOME, 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 without Switches, 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 | Rotating 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 | 12.6CM TAPERED 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 | XMAX Motor, High Strength 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 | 14cm QD Angle Attachment Product Usage: Product attachment | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | IMRI AIR CONTROL 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 | SMALL ATTACHMENT, J-LATCH | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | 6.8cm Controlled Depth 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 | Electric Handpiece EM 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 | 14cm 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 | Keyless 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 | SCC Soft Computer Softbank II software Product Usage: Supports single and... | Software error. Potential for incorrect results | Class II | Soft Computer Consultants, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 8F C70¿ S79CM D84CM Catalog # AB081045 Is designed... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 8F C120¿ S61CM D66CM Catalog # AB081043 Is design... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed ... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is des... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 8F C120¿ S79CM D84CM Catalog # AB081047 Is design... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 8F C70¿ S61CM D66CM Catalog # AB081041 Is designed... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 10F C120¿ S79CM D84CM Catalog # AB101078 Is desig... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 10F C120¿ S61CM D66CM Catalog # AB101075 Is desig... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 10F C55¿ S61CM D66CM Catalog # AB101072 Is designe... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed ... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S79CM D84CM GLOBAL Cat... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBAL Cata... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 10F C70¿ S79CM D84CM Catalog # AB101077 Is design... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 8F C55¿ S79CM D84CM Catalog # AB081044 Is designed... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is de... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C120¿ S61CM D66CM GLOBAL Cat... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is des... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 8F C55¿ S61CM D66CM Catalog # AB081040 Is designed... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 8F C90¿ S61CM D66CM Catalog # AB081042 Is designed... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S61CM D66CM GLOBALCatal... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C55¿ S79CM D84CM GLOBAL Cat... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 10F C70¿ S61CM D66CM Catalog # AB101073 Is design... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 10F C55¿ S79CM D84CM Catalog # AB101076 Is design... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is desi... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Ca... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | OSCOR ADELANTE BREEZEWAY 10F C90¿ S79CM D84CM Catalog # AB101078 Is designe... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S61CM D66CM GLOBAL Cata... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, Inc. |
| Oct 5, 2016 | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C90¿ S79CM D84CM GLOBAL Cat... | Complaint that during insertion of the dilator through the sheath a fragment of inner liner came... | Class II | Oscor, 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.