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Medical device recalls: June 2008

The FDA posted 51 medical device recall records in June 2008, from 22 recall events by 19 companies. 51 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, 8 records
  2. AGFA Corp. · 2 events, 2 records
  3. GE Healthcare · 2 events, 2 records
  4. Chattanooga Corp Inc · 1 event, 15 records
  5. Bio-Rad Laboratories · 1 event, 4 records
  6. California Medical Laboratories Inc · 1 event, 3 records
  7. Cardinal Health 303 Inc DBA Alaris Products · 1 event, 3 records
  8. Medline Industries Inc · 1 event, 3 records

FDA root cause

  1. Device Design · 23
  2. Process design · 7
  3. Process control · 7
  4. Software design · 5
  5. Nonconforming Material/Component · 4
  6. Software change control · 1
  7. Process change control · 1
  8. Other · 1

Not yet classified (51)

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.