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Medical device recalls: February 2014

The FDA posted 205 medical device recall records in February 2014, from 103 recall events by 72 companies. 30 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. Philips Medical Systems, Inc. · 7 events, 7 records
  2. GE Healthcare, LLC · 6 events, 8 records, 3 Class I
  3. Elekta, Inc. · 4 events, 4 records
  4. Zimmer, Inc. · 3 events, 46 records
  5. Ortho-Clinical Diagnostics · 3 events, 5 records
  6. Philips Medical Systems (Cleveland) Inc · 3 events, 3 records
  7. Synthes, Inc. · 3 events, 3 records
  8. Fresenius Medical Care Holdings, Inc. · 2 events, 10 records

FDA root cause

  1. Packaging · 44
  2. Under Investigation by firm · 23
  3. Nonconforming Material/Component · 23
  4. Device Design · 19
  5. Other · 18
  6. Software design · 17
  7. Process control · 15
  8. Component design/selection · 11

Class I recalls (30)

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

Class II recalls (171)

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

Class III recalls (4)

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.