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Medical device recalls: November 2005

The FDA posted 147 medical device recall records in November 2005, from 69 recall events by 57 companies. 147 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, 3 records
  2. Ekos Corp · 3 events, 3 records
  3. Terumo Cardiovascular Systems Corp · 3 events, 3 records
  4. Stryker Howmedica Osteonics Corp. · 2 events, 9 records
  5. Siemens Medical Solutions USA, Inc · 2 events, 7 records
  6. Hospira Inc. · 2 events, 4 records
  7. Baxter Healthcare Renal Div · 2 events, 2 records
  8. Ortho-Clinical Diagnostics · 2 events, 2 records

FDA root cause

  1. Other · 145
  2. Process design · 1
  3. Process control · 1

Not yet classified (147)

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.