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Medical device recalls: June 2010

The FDA posted 178 medical device recall records in June 2010, from 64 recall events by 57 companies. 178 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. Ge Healthcare, Llc · 4 events, 6 records
  2. Boston Scientific Corporation · 3 events, 60 records
  3. Beckman Coulter Inc. · 2 events, 3 records
  4. Cardiac Science Corporation · 2 events, 2 records
  5. Angiodynamics, Inc. · 1 event, 11 records
  6. Argon Medical Devices, Inc · 1 event, 9 records
  7. Abbott Point of Care Inc. · 1 event, 8 records
  8. Rochester Medical Corp · 1 event, 8 records

FDA root cause

  1. Device Design · 65
  2. Other · 49
  3. Nonconforming Material/Component · 15
  4. Process control · 10
  5. Package design/selection · 9
  6. Packaging · 8
  7. Software design · 6
  8. PMA · 6

Not yet classified (178)

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.