Skip to content

Medical device recalls: July 2010

The FDA posted 166 medical device recall records in July 2010, from 43 recall events by 40 companies. 166 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. AGFA Corp. · 2 events, 2 records
  2. Starion Instruments · 2 events, 2 records
  3. Toshiba American Medical Systems Inc · 2 events, 2 records
  4. Depuy Orthopaedics, Inc. · 1 event, 29 records
  5. Cook, Inc. · 1 event, 17 records
  6. Oridion Medical 1987 Ltd. · 1 event, 16 records
  7. Navilyst Medical, Inc · 1 event, 14 records
  8. Stryker Spine · 1 event, 12 records

FDA root cause

  1. Other · 54
  2. Nonconforming Material/Component · 36
  3. Process design · 20
  4. Process control · 19
  5. Software design · 13
  6. Package design/selection · 6
  7. Device Design · 4
  8. Component change control · 4

Not yet classified (166)

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.