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Medical device recalls: May 2011

The FDA posted 277 medical device recall records in May 2011, from 115 recall events by 70 companies. 277 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. Beckman Coulter Inc. · 15 events, 17 records
  2. Varian Medical Systems, Inc. Oncology Systems · 7 events, 7 records
  3. Integra LifeSciences Corp. · 5 events, 5 records
  4. Siemens Medical Solutions USA, Inc · 4 events, 4 records
  5. Philips Healthcare Inc. · 3 events, 4 records
  6. Baxter Healthcare Corp. · 3 events, 3 records
  7. Digisonics, Inc · 3 events, 3 records
  8. Newport Medical Instruments Inc · 3 events, 3 records

FDA root cause

  1. Material/Component Contamination · 89
  2. Other · 83
  3. Software design · 21
  4. Device Design · 21
  5. Equipment maintenance · 10
  6. Pending · 8
  7. Component change control · 7
  8. Package design/selection · 6

Not yet classified (277)

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.