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Medical device recalls: August 2011

The FDA posted 217 medical device recall records in August 2011, from 127 recall events by 91 companies. 217 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, Inc. Oncology Systems · 12 events, 19 records
  2. Spacelabs Healthcare, Llc · 5 events, 5 records
  3. Baxter Healthcare Corp. · 4 events, 4 records
  4. Applied Medical Resources Corp · 3 events, 10 records
  5. Boston Scientific Corporation · 3 events, 3 records
  6. Siemens Medical Solutions USA, Inc · 3 events, 3 records
  7. Stryker Medical Division of Stryker Corporation · 2 events, 9 records
  8. Bausch & Lomb Inc · 2 events, 5 records

FDA root cause

  1. Other · 41
  2. Nonconforming Material/Component · 40
  3. Device Design · 40
  4. Software design · 31
  5. Labeling False and Misleading · 9
  6. Error in labeling · 7
  7. Component design/selection · 7
  8. Process control · 6

Not yet classified (217)

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.