Browse Device Recalls
3,029 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,029 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 3,029 FDA device recalls in 2016.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, infla... | AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device ... | Class II | AccessClosure, Inc., A Cardinal Health Company |
| 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 | Softbank software Product Usage: Decision support software for transfusio... | Software error. Potential for incorrect results | Class II | Soft Computer Consultants, 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. |
| 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. |
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.