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Medical device recalls: August 2014

The FDA posted 424 medical device recall records in August 2014, from 92 recall events by 64 companies. 244 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. Zimmer, Inc. · 9 events, 43 records
  2. Nanosphere, Inc. · 4 events, 4 records
  3. Ortho-Clinical Diagnostics · 3 events, 5 records
  4. AGFA Healthcare Corp. · 3 events, 3 records
  5. Medtronic MiniMed Inc. · 3 events, 3 records
  6. ICU Medical, Inc. · 2 events, 12 records
  7. Carestream Health Inc. · 2 events, 3 records
  8. BioMerieux SA · 2 events, 2 records

FDA root cause

  1. Package design/selection · 250
  2. Device Design · 56
  3. Nonconforming Material/Component · 17
  4. Error in labeling · 17
  5. Software design · 12
  6. Under Investigation by firm · 9
  7. Component design/selection · 9
  8. Packaging process control · 8

Class I recalls (244)

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

Class II recalls (172)

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

Class III recalls (8)

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.