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Medical device recalls: September 2013

The FDA posted 195 medical device recall records in September 2013, from 92 recall events by 72 companies. 22 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 · 8 events, 8 records
  2. B Braun Medical, Inc. · 4 events, 4 records, 1 Class I
  3. CareFusion 303, Inc. · 3 events, 3 records
  4. Elekta, Inc. · 3 events, 3 records
  5. Synthes USA HQ, Inc. · 3 events, 3 records
  6. Becton Dickinson & Company · 2 events, 2 records
  7. Ebi, Llc · 2 events, 2 records
  8. King Systems Corp. · 2 events, 2 records, 1 Class I

FDA root cause

  1. Process control · 32
  2. Packaging · 28
  3. Device Design · 23
  4. Material/Component Contamination · 22
  5. Package design/selection · 14
  6. Software design · 11
  7. Use error · 9
  8. Nonconforming Material/Component · 6

Class I recalls (22)

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

Class II recalls (171)

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.