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Medical device recalls: January 2010

The FDA posted 171 medical device recall records in January 2010, from 43 recall events by 37 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. GE Medical Systems, LLC · 4 events, 11 records
  2. Stryker Instruments Div. of Stryker Corporation · 2 events, 30 records
  3. Ge Healthcare · 2 events, 7 records
  4. Biomet, Inc. · 2 events, 2 records
  5. B. Braun Medical, Inc. · 1 event, 49 records
  6. Sorin Group USA, Inc. · 1 event, 7 records
  7. Gyrus ACMI Corporation · 1 event, 6 records
  8. KCI USA, Inc. · 1 event, 6 records

FDA root cause

  1. Nonconforming Material/Component · 57
  2. Packaging process control · 27
  3. Device Design · 27
  4. Radiation Control for Health and Safety Act · 13
  5. Component change control · 9
  6. Process control · 7
  7. Environmental control · 6
  8. Error in labeling · 5

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.