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Medical device recalls: April 2011

The FDA posted 261 medical device recall records in April 2011, from 111 recall events by 70 companies. 261 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. · 18 events, 42 records
  2. Siemens Medical Solutions USA, Inc. · 8 events, 11 records
  3. Varian Medical Systems, Inc. Oncology Systems · 4 events, 4 records
  4. Bio-Rad Laboratories Inc · 3 events, 3 records
  5. Siemens Medical Solutions USA, Inc · 3 events, 3 records
  6. Terumo Cardiovascular Systems Corporation · 2 events, 14 records
  7. King Systems Corp. · 2 events, 8 records
  8. Hospira Inc. · 2 events, 5 records

FDA root cause

  1. Other · 86
  2. Device Design · 32
  3. Software design · 26
  4. Employee error · 22
  5. Pending · 20
  6. Process control · 12
  7. Environmental control · 12
  8. Nonconforming Material/Component · 9

Not yet classified (261)

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.