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Medical device recalls: January 2011

The FDA posted 172 medical device recall records in January 2011, from 75 recall events by 60 companies. 172 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. Varian Medical Systems Oncology Systems · 6 events, 6 records
  2. Accuray Inc · 3 events, 4 records
  3. Baxter Healthcare Corp. · 3 events, 3 records
  4. Stryker Endoscopy · 3 events, 3 records
  5. Boston Scientific Corporation · 2 events, 15 records
  6. Terumo Cardiovascular Systems Corporation · 2 events, 3 records
  7. Arrow International Inc · 2 events, 2 records
  8. Merit Medical Systems, Inc. · 2 events, 2 records

FDA root cause

  1. Device Design · 35
  2. Other · 33
  3. Radiation Control for Health and Safety Act · 24
  4. Process control · 14
  5. Labeling False and Misleading · 13
  6. Packaging process control · 12
  7. Component design/selection · 12
  8. Software design · 6

Not yet classified (172)

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.