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Medical device recalls: November 2010

The FDA posted 318 medical device recall records in November 2010, from 100 recall events by 71 companies. 318 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 · 8 events, 15 records
  2. SCC Soft Computer · 5 events, 5 records
  3. Philips Medical Systems · 4 events, 12 records
  4. Abbott Point of Care Inc. · 3 events, 6 records
  5. Boston Scientific Corporation · 3 events, 4 records
  6. Philips Medical Systems North America Co. Phillips · 3 events, 3 records
  7. Ethicon Endo-Surgery Inc · 2 events, 17 records
  8. Siemens Healthcare Diagnostics, Inc. · 2 events, 5 records

FDA root cause

  1. Nonconforming Material/Component · 138
  2. Other · 56
  3. Packaging process control · 33
  4. Device Design · 31
  5. Software design · 16
  6. Pending · 12
  7. Component design/selection · 7
  8. Process control · 6

Not yet classified (318)

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.