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Medical device recalls: September 2010

The FDA posted 309 medical device recall records in September 2010, from 110 recall events by 76 companies. 309 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. · 10 events, 13 records
  2. Philips Medical Systems North America Co. Phillips · 7 events, 22 records
  3. Siemens Healthcare Diagnostics, Inc. · 6 events, 6 records
  4. Stryker Instruments Div. of Stryker Corporation · 3 events, 29 records
  5. Invacare Corporation · 3 events, 3 records
  6. Zimmer Inc. · 2 events, 13 records
  7. Biomet, Inc. · 2 events, 11 records
  8. Terumo Cardiovascular Corporation · 2 events, 9 records

FDA root cause

  1. Device Design · 97
  2. Other · 69
  3. Process control · 34
  4. Nonconforming Material/Component · 23
  5. Equipment maintenance · 18
  6. Mixed-up of materials/components · 10
  7. Packaging change control · 9
  8. Software design · 8

Not yet classified (309)

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.