Skip to content

Medical device recalls: May 2010

The FDA posted 287 medical device recall records in May 2010, from 79 recall events by 61 companies. 287 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. Bausch & Lomb Inc · 3 events, 26 records
  2. Stryker Howmedica Osteonics Corp. · 3 events, 19 records
  3. Beckman Coulter Inc. · 3 events, 4 records
  4. Leica Microsystems, Inc. · 3 events, 4 records
  5. Boston Scientific CRM Corp · 2 events, 8 records
  6. Stryker Communications Corp · 2 events, 7 records
  7. Blackstone Medical, Inc. · 2 events, 6 records
  8. Ge Healthcare, Llc · 2 events, 5 records

FDA root cause

  1. Process design · 65
  2. Device Design · 61
  3. Process control · 25
  4. Nonconforming Material/Component · 25
  5. Component design/selection · 24
  6. Other · 20
  7. Process change control · 17
  8. Software design · 14

Not yet classified (287)

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.