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.

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DateProductReasonClassFirm
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.