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Medical device recalls: June 2014

The FDA posted 272 medical device recall records in June 2014, from 123 recall events by 85 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. Ortho-Clinical Diagnostics · 5 events, 8 records
  2. Siemens Medical Solutions USA, Inc · 5 events, 5 records
  3. Elekta, Inc. · 4 events, 4 records
  4. Siemens Healthcare Diagnostics, Inc. · 4 events, 4 records
  5. Philips Medical Systems, Inc. · 3 events, 7 records
  6. Biomet, Inc. · 3 events, 6 records
  7. Leica Microsystems, Inc. · 3 events, 4 records
  8. Philips Medical Systems (Cleveland) Inc · 3 events, 3 records

FDA root cause

  1. Nonconforming Material/Component · 49
  2. Process design · 46
  3. Device Design · 37
  4. Software design · 19
  5. Packaging process control · 18
  6. Use error · 12
  7. Material/Component Contamination · 12
  8. Equipment maintenance · 12

Class I recalls (19)

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

Class II recalls (246)

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

Class III recalls (7)

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.