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Medical device recalls: January 2016

The FDA posted 118 medical device recall records in January 2016, from 53 recall events by 50 companies. 7 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. Boston Scientific Corporation · 2 events, 3 records
  2. Cyberonics, Inc · 2 events, 2 records
  3. Stryker Sustainability Solutions · 2 events, 2 records, 1 Class I
  4. Philips Electronics North America Corporation · 1 event, 29 records
  5. Siemens Healthcare Diagnostics Inc · 1 event, 11 records
  6. Perkinelmer · 1 event, 7 records
  7. GE Medical Systems, LLC · 1 event, 6 records
  8. Biomet 3i, LLC · 1 event, 4 records

FDA root cause

  1. Device Design · 40
  2. Nonconforming Material/Component · 17
  3. Labeling design · 11
  4. Process control · 10
  5. Software design · 8
  6. Under Investigation by firm · 7
  7. Process design · 5
  8. Component design/selection · 5

Class I recalls (7)

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

Class II recalls (110)

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

Class III recalls (1)

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.