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Medical device recalls: April 2010

The FDA posted 262 medical device recall records in April 2010, from 84 recall events by 59 companies. 262 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. Elekta, Inc. · 14 events, 14 records
  2. Orthohelix Surgical Designs Inc · 3 events, 3 records
  3. Siemens Medical Solutions USA, Inc · 3 events, 3 records
  4. Philips Healthcare Inc. · 2 events, 54 records
  5. Cardiac Science Corporation · 2 events, 8 records
  6. Pelton & Crane Company · 2 events, 6 records
  7. Ge Healthcare It · 2 events, 4 records
  8. Mindray DS USA, Inc., dba Datascope Patient Monitoring · 2 events, 4 records

FDA root cause

  1. Nonconforming Material/Component · 76
  2. Component design/selection · 68
  3. Other · 33
  4. Process control · 28
  5. Device Design · 19
  6. Software design · 15
  7. Mixed-up of materials/components · 3
  8. Labeling mix-ups · 3

Not yet classified (262)

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.