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Medical device recalls: April 2008

The FDA posted 180 medical device recall records in April 2008, from 29 recall events by 28 companies. 180 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. Siemens Medical Solutions USA, Inc · 2 events, 25 records
  2. Stryker Instruments Div. of Stryker Corporation · 1 event, 47 records
  3. Respironics, Inc. · 1 event, 39 records
  4. Cook, Inc. · 1 event, 13 records
  5. Zimmer Inc. · 1 event, 11 records
  6. Baxter Healthcare Corp. · 1 event, 10 records
  7. Boston Scientific Corporation · 1 event, 9 records
  8. Coloplast Corp · 1 event, 3 records

FDA root cause

  1. Package design/selection · 61
  2. Environmental control · 39
  3. Software design · 31
  4. Process control · 12
  5. Nonconforming Material/Component · 10
  6. Device Design · 10
  7. Process design · 4
  8. Error in labeling · 3

Not yet classified (180)

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.