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Medical device recalls: September 2012

The FDA posted 186 medical device recall records in September 2012, from 108 recall events by 81 companies. 12 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. Steris Corporation · 5 events, 5 records
  2. Philips Healthcare Inc. · 4 events, 4 records
  3. Siemens Medical Solutions USA, Inc · 4 events, 4 records
  4. Philips Medical Systems (Cleveland) Inc · 3 events, 3 records
  5. Raysearch Laboratories AB · 3 events, 3 records
  6. Terumo Cardiovascular Systems Corporation · 3 events, 3 records
  7. Custom Medical Specialties, Inc. · 2 events, 16 records, 12 Class I
  8. Zimmer, Inc. · 2 events, 13 records

FDA root cause

  1. Device Design · 48
  2. Nonconforming Material/Component · 31
  3. Software design · 18
  4. Material/Component Contamination · 16
  5. Error in labeling · 9
  6. Packaging · 8
  7. Process control · 7
  8. Process change control · 7

Class I recalls (12)

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

Class II recalls (161)

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

Class III recalls (13)

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.