Browse Device Recalls
261 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 261 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 261 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Oct 6, 2016 | AL-III-DISS Adapter 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 MIN INVASIVE ATTACH, BLACK MAX | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | eMax2 Motor Assembly 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 CRANI-A 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 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 | 90 DEG RIGHT ANGLE ATTACH, BLACK MAX | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | 45 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 | 12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic sy... | 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, no irrigation | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | 14CM 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 | 7.5CM 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 | GREEN ROTATING CRANIOTOME, BLACK MAX | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | 8.0CM Heavy Duty 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 | Bearing Sleeve, 19CM 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 | ADJUSTABLE DRILL GUIDE, BLACK MAX | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | CONTRA 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 | 9.4CM 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 | 10.5cm Long 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 | 10.5cm Long Attachment, Non-Tapered End 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 | 7.5cm QD Angle Attachment | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | 6.1CM 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 | Compact Speed Reducer, 60:1 | 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 | Reciprocating MICRO SAW | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | 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 | Autolube-III with 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 | Bearing Sleeve, 10CM 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 | 26.65CM ATTACHMENT, BLACK MAX | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | 13.5CM 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 | 8cm QD Angle Attachment | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | Large 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 | 5.0cm Short Attachment | Supplied Directions for Use (DFU) did not contain a recommended service interval. | Class II | The Anspach Effort, Inc. |
| Oct 6, 2016 | Autolube-III with Irrigation 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 | 11.0cm Long 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 | Autolube-III with Foot Guard 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 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 | 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. |
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.