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Medical device recalls: May 2009

The FDA posted 118 medical device recall records in May 2009, from 49 recall events by 43 companies. 118 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. Roche Diagnostics Corp. · 2 events, 3 records
  2. Siemens Medical Solutions USA, Inc · 2 events, 3 records
  3. Synthes Spine · 2 events, 3 records
  4. Abbott Laboratories · 2 events, 2 records
  5. Philips Healthcare Inc. · 2 events, 2 records
  6. Zimmer Inc. · 2 events, 2 records
  7. Argon Medical Devices, Inc · 1 event, 41 records
  8. Boston Scientific Corporation · 1 event, 17 records

FDA root cause

  1. Other · 43
  2. Labeling False and Misleading · 18
  3. Process control · 17
  4. Device Design · 9
  5. Software design · 8
  6. Nonconforming Material/Component · 5
  7. Process change control · 3
  8. Component design/selection · 3

Not yet classified (118)

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.