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Medical device recalls: November 2011

The FDA posted 173 medical device recall records in November 2011, from 93 recall events by 72 companies. 173 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. AGFA Corp. · 4 events, 4 records
  2. Elekta, Inc. · 4 events, 4 records
  3. SCC Soft Computer · 4 events, 4 records
  4. Terumo Cardiovascular Systems Corporation · 3 events, 6 records
  5. Philips Medical Systems · 2 events, 13 records
  6. Kerr/pentron Dba Kerr Corporation And Pentron Clinical · 2 events, 6 records
  7. Biomet 3i, LLC · 2 events, 3 records
  8. Ormco Corporation · 2 events, 3 records

FDA root cause

  1. Packaging · 38
  2. Device Design · 26
  3. Nonconforming Material/Component · 21
  4. Employee error · 17
  5. Software design · 15
  6. Process control · 11
  7. Material/Component Contamination · 9
  8. Component design/selection · 6

Not yet classified (173)

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.