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Medical device recalls: January 2014

The FDA posted 291 medical device recall records in January 2014, from 123 recall events by 83 companies. 3 are Class I, the most serious category.

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. The Anspach Effort, Inc. · 9 events, 37 records
  2. GE Healthcare, LLC · 8 events, 10 records
  3. Siemens Healthcare Diagnostics, Inc. · 5 events, 6 records
  4. Ge Healthcare It · 5 events, 5 records
  5. Philips Medical Systems (Cleveland) Inc · 5 events, 5 records
  6. Boston Scientific Corporation · 3 events, 10 records
  7. Codman & Shurtleff, Inc. · 2 events, 9 records, 2 Class I
  8. Remel Inc · 2 events, 5 records

FDA root cause

  1. Equipment maintenance · 51
  2. Device Design · 48
  3. Use error · 28
  4. Labeling Change Control · 28
  5. Software design · 19
  6. Nonconforming Material/Component · 19
  7. Under Investigation by firm · 18
  8. Process design · 10

Class I recalls (3)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

Class II recalls (286)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Class III recalls (2)

Using the device is not likely to cause health problems, but it violates FDA rules.

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.