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Medical device recalls: November 2015

The FDA posted 105 medical device recall records in November 2015, from 81 recall events by 69 companies. 5 are Class I, the most serious category.

Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.

Companies with the most recall events

  1. Philips Medical Systems, Inc. · 4 events, 4 records
  2. Stryker Howmedica Osteonics Corp. · 3 events, 3 records
  3. Boston Scientific Corporation · 2 events, 3 records, 2 Class I
  4. DeRoyal Industries Inc · 2 events, 3 records
  5. Medtronic Inc. · 2 events, 2 records
  6. Ortho-Clinical Diagnostics · 2 events, 2 records
  7. Philips Electronics North America Corporation · 2 events, 2 records
  8. Siemens Healthcare Diagnostics, Inc. · 2 events, 2 records

FDA root cause

  1. Device Design · 18
  2. Under Investigation by firm · 13
  3. Software design · 13
  4. Process design · 9
  5. Labeling mix-ups · 6
  6. Unknown/Undetermined by firm · 5
  7. Process control · 5
  8. Packaging process control · 5

Class I recalls (5)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

Class II recalls (94)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Class III recalls (6)

Using the device is not likely to cause health problems, but it violates FDA rules.

Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.