Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall XMAX Motor, High Strength Hose Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Electric Handpiece EM Hand Control Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Electronic Foot Control with Direction Switch Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall eMax2 Motor Assembly Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall eMax2 Hybrid Hand Control Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall eMax2 PLUS Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Foot Control, SC2100 Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Foot Control without Switches, SC2100 Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Console, eMax2 Plus Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall System Console, Single Port, with irrigation Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall System Console, Single Port, no irrigation Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 7.2cm Adjustable Drill Guide Product Usage: Electric system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 19CM ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 11.25CM ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall LARGE CRANIOTOME, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall STANDARD CRANIOTOME, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall GREEN ROTATING CRANIOTOME, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall ADJUSTABLE DRILL GUIDE, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 16CM MIN INVASIVE ATTACH, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall KEYLESS DRIVER, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 22CM MICRO REVISION ATTACH, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 16.5CM MICRO REVISION ATTACH, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 9.4CM MICRO REVISION ATTACH, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall CONTRA ANGLE ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 90 DEG RIGHT ANGLE ATTACH, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 11CM ANGLE ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 10.5CM ANGLE ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 14CM ANGLE ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 13.5CM ANGLE ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 8CM ANGLE ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 7.5CM ANGLE ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 26.65CM ATTACHMENT, BLACK MAX Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall B-SAGITTAL ASSEMBLY Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 6.1CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 12.6CM TAPERED ATTACHMENT, BLACK MAX Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 5.9CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall PEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 8.2CM ATTACHMENT, BLACK MAX Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 6.8cm Controlled Depth Attachment Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Adult Craniotome Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall 6.5CM ADLT CRANI, THIN FT PLATE Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Rotating Adult Craniotome Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Large Craniotome Product Usage: Pneumatic system Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Rotating Large Craniotome Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Pediatric Craniotome Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
- Medical device recall Compact Speed Reducer, 60:1 Supplied Directions for Use (DFU) did not contain a recommended service interval. Class IIFDA’s classMay 10, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 10, 2017ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Hawaii and Puerto Rico named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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