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Medical device recalls: October 2010

The FDA posted 170 medical device recall records in October 2010, from 88 recall events by 63 companies. 170 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. SCC Soft Computer · 9 events, 9 records
  2. Zimmer Inc. · 5 events, 14 records
  3. Philips Medical Systems North America Co. Phillips · 5 events, 8 records
  4. Baxter Healthcare Corp. · 3 events, 14 records
  5. Stryker Howmedica Osteonics Corp. · 2 events, 10 records
  6. Stryker Instruments Div. of Stryker Corporation · 2 events, 4 records
  7. Verathon, Inc. · 2 events, 4 records
  8. Beckman Coulter Inc. · 2 events, 2 records

FDA root cause

  1. Other · 40
  2. Software design · 31
  3. Device Design · 23
  4. Component design/selection · 17
  5. Employee error · 15
  6. Package design/selection · 12
  7. Process control · 6
  8. Nonconforming Material/Component · 5

Not yet classified (170)

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.