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Medical device recalls: October 2013

The FDA posted 118 medical device recall records in October 2013, from 77 recall events by 60 companies. 8 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. GE Healthcare, LLC · 5 events, 6 records, 2 Class I
  2. Philips Medical Systems (Cleveland) Inc · 5 events, 5 records
  3. Ge Healthcare It · 3 events, 3 records
  4. Intuitive Surgical, Inc. · 2 events, 3 records
  5. Advanced Sterilization Products · 2 events, 2 records
  6. Baxter Healthcare Corp. · 2 events, 2 records
  7. Carestream Health, Inc. · 2 events, 2 records
  8. Cordis Corporation · 2 events, 2 records

FDA root cause

  1. Nonconforming Material/Component · 21
  2. Package design/selection · 13
  3. Device Design · 12
  4. Software design · 11
  5. Under Investigation by firm · 10
  6. Software Manufacturing/Software Deployment · 8
  7. Error in labeling · 8
  8. Process control · 5

Class I recalls (8)

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

Class II recalls (108)

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

Class III recalls (2)

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.