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Medical device recalls: October 2014

The FDA posted 162 medical device recall records in October 2014, from 103 recall events by 80 companies. 19 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. Siemens Healthcare Diagnostics, Inc · 3 events, 8 records
  2. Biomet, Inc. · 3 events, 5 records
  3. Arrow International Inc · 3 events, 3 records
  4. Siemens Healthcare Diagnostics, Inc. · 3 events, 3 records
  5. Siemens Medical Solutions USA, Inc · 2 events, 5 records
  6. Baxter Healthcare Corp · 2 events, 3 records, 2 Class I
  7. Ortho-Clinical Diagnostics · 2 events, 3 records
  8. Philips Medical Systems, Inc. · 2 events, 3 records

FDA root cause

  1. Device Design · 37
  2. Nonconforming Material/Component · 26
  3. Process control · 20
  4. Software design · 10
  5. Mixed-up of materials/components · 10
  6. Labeling Change Control · 7
  7. Material/Component Contamination · 6
  8. Equipment maintenance · 5

Class I recalls (19)

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

Class II recalls (139)

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.