Skip to content

Medical device recalls: June 2007

The FDA posted 129 medical device recall records in June 2007, from 57 recall events by 43 companies. 129 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. Terumo Cardiovascular Systems Corp · 6 events, 12 records
  2. Roche Diagnostics Corp. · 4 events, 6 records
  3. General Electric Med Systems LLC · 3 events, 7 records
  4. Philips Medical Systems North America Co. Phillips · 2 events, 5 records
  5. Medtronic Emergency Response Systems, Inc. · 2 events, 3 records
  6. Biomet 3i · 2 events, 2 records
  7. Smith & Nephew, Inc Endoscopy Division · 2 events, 2 records
  8. Conmed Endoscopic Technologies, Inc. · 1 event, 13 records

FDA root cause

  1. Other · 122
  2. Nonconforming Material/Component · 4
  3. Software design · 2
  4. Process control · 1

Not yet classified (129)

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.