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Medical device recalls: February 2013

The FDA posted 139 medical device recall records in February 2013, from 83 recall events by 63 companies. 8 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. GE Healthcare, LLC · 6 events, 8 records, 2 Class I
  2. Philips Medical Systems (Cleveland) Inc · 4 events, 7 records
  3. Remel Inc · 4 events, 5 records
  4. Philips Healthcare Inc. · 4 events, 4 records
  5. Ultradent Products, Inc. · 2 events, 3 records
  6. Aesculap, Inc. · 2 events, 2 records
  7. Elekta, Inc. · 2 events, 2 records
  8. Integra LifeSciences Corp. · 2 events, 2 records

FDA root cause

  1. Component design/selection · 31
  2. Software design · 18
  3. Process control · 17
  4. Nonconforming Material/Component · 15
  5. Device Design · 13
  6. Packaging · 6
  7. Material/Component Contamination · 6
  8. Unknown/Undetermined by firm · 4

Class I recalls (8)

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

Class II recalls (125)

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

Class III recalls (6)

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.