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Medical device recalls: January 2004

The FDA posted 171 medical device recall records in January 2004, from 35 recall events by 29 companies. 171 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. Abbott Laboratories HPD/ADD/GPRD · 2 events, 6 records
  2. Hill-Rom, Inc. · 2 events, 3 records
  3. Baxter Healthcare Corp. · 2 events, 2 records
  4. I-Flow Corporation · 2 events, 2 records
  5. Ortho-Clinical Diagnostics · 2 events, 2 records
  6. Wilson-Cook Medical Inc · 2 events, 2 records
  7. Depuy Orthopaedics, Inc. · 1 event, 116 records
  8. Heartport Inc · 1 event, 5 records

FDA root cause

  1. Other · 170
  2. Process control · 1

Not yet classified (171)

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.