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Medical device recalls: September 2005

The FDA posted 140 medical device recall records in September 2005, from 39 recall events by 34 companies. 140 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. Baxter Healthcare Corp. · 3 events, 5 records
  2. North Coast Medi-Tek Inc · 3 events, 3 records
  3. Boston Scientific Corporation · 2 events, 63 records
  4. Becton Dickinson Medical Systems · 1 event, 9 records
  5. Angiomed Gmbh · 1 event, 7 records
  6. Scanlan International Inc · 1 event, 7 records
  7. Linvatec Corp. · 1 event, 5 records
  8. Fischer Imaging Corporation · 1 event, 4 records

FDA root cause

  1. Other · 136
  2. Labeling design · 2
  3. Nonconforming Material/Component · 1
  4. Device Design · 1

Not yet classified (140)

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.