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Medical device recalls: June 2006

The FDA posted 237 medical device recall records in June 2006, from 48 recall events by 41 companies. 237 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. Hitachi Medical Systems America Inc · 6 events, 6 records
  2. Ev3, Inc · 2 events, 3 records
  3. Ethicon, Inc. · 2 events, 2 records
  4. Medtronic, Inc. · 1 event, 147 records
  5. Edwards Lifesciences Research Medical, Inc. · 1 event, 7 records
  6. MDS Canada Inc. DBA MDS Nordion · 1 event, 7 records
  7. Boston Scientific Corp · 1 event, 6 records
  8. Guidant Endovascular Solutions, Inc. · 1 event, 6 records

FDA root cause

  1. Other · 233
  2. Packaging process control · 3
  3. Nonconforming Material/Component · 1

Not yet classified (237)

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.