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Medical device recalls: October 2011

The FDA posted 141 medical device recall records in October 2011, from 71 recall events by 61 companies. 141 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. Beckman Coulter Inc. · 3 events, 11 records
  2. GE Healthcare, LLC · 3 events, 4 records
  3. Siemens Healthcare Diagnostics, Inc. · 3 events, 3 records
  4. Philips Healthcare Inc. · 2 events, 4 records
  5. Terumo Cardiovascular Systems Corporation · 2 events, 3 records
  6. B Braun Medical, Inc · 2 events, 2 records
  7. Invivo Corporation · 2 events, 2 records
  8. The Anspach Effort, Inc. · 1 event, 13 records

FDA root cause

  1. Nonconforming Material/Component · 31
  2. Software design · 23
  3. Process control · 18
  4. Employee error · 15
  5. Incorrect or no expiration date · 12
  6. Device Design · 11
  7. Material/Component Contamination · 6
  8. Equipment maintenance · 5

Not yet classified (141)

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.