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Medical device recalls: July 2011

The FDA posted 175 medical device recall records in July 2011, from 98 recall events by 71 companies. 175 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. Varian Medical Systems, Inc. Oncology Systems · 7 events, 7 records
  2. Beckman Coulter Inc. · 5 events, 8 records
  3. Biomet Microfixation, Inc. · 3 events, 6 records
  4. Cincinnati Sub-Zero Products Inc · 3 events, 4 records
  5. Baxter Healthcare Corp. · 3 events, 3 records
  6. Biomet 3i, LLC · 3 events, 3 records
  7. Terumo Cardiovascular Systems Corporation · 2 events, 5 records
  8. Toshiba American Medical Systems Inc · 2 events, 3 records

FDA root cause

  1. Device Design · 27
  2. Other · 24
  3. Equipment maintenance · 22
  4. Nonconforming Material/Component · 18
  5. Process control · 16
  6. Software design · 13
  7. Pending · 9
  8. Employee error · 8

Not yet classified (175)

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.