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Medical device recalls: September 2011

The FDA posted 169 medical device recall records in September 2011, from 74 recall events by 58 companies. 169 have not been classified yet.

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 (Cleveland) Inc · 3 events, 6 records
  2. Angiodynamics Worldwide Headquarters · 3 events, 5 records
  3. GE Healthcare, LLC · 3 events, 5 records
  4. Beckman Coulter Inc. · 3 events, 3 records
  5. The Anspach Effort, Inc. · 2 events, 7 records
  6. Toshiba American Medical Systems Inc · 2 events, 5 records
  7. Boston Scientific CRM Corp · 2 events, 2 records
  8. Lee Medical International Inc · 2 events, 2 records

FDA root cause

  1. Nonconforming Material/Component · 48
  2. Process control · 34
  3. Software design · 17
  4. Employee error · 17
  5. Other · 11
  6. Storage · 8
  7. Pending · 7
  8. Device Design · 6

Not yet classified (169)

The FDA has posted these records but has not published a class for them yet.

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.