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Medical device recalls: July 2008

The FDA posted 141 medical device recall records in July 2008, from 32 recall events by 29 companies. 141 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. Stryker Howmedica Osteonics Corp. · 2 events, 18 records
  2. AGFA Corp. · 2 events, 2 records
  3. Arjo, Inc. · 2 events, 2 records
  4. Edwards Lifesciences, Llc · 1 event, 51 records
  5. Beckman Coulter Inc · 1 event, 18 records
  6. Medtronic Perfusion Systems · 1 event, 12 records
  7. Zimmer Inc. · 1 event, 6 records
  8. Parks Medical Electronics Inc · 1 event, 4 records

FDA root cause

  1. Packaging process control · 61
  2. Software design · 23
  3. Process control · 21
  4. Nonconforming Material/Component · 20
  5. Device Design · 7
  6. Labeling mix-ups · 3
  7. Component design/selection · 3
  8. Release of Material/Component prior to receiving test results · 1

Not yet classified (141)

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.