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Medical device recalls: June 2015

The FDA posted 188 medical device recall records in June 2015, from 112 recall events by 76 companies. 6 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. HeartWare Inc · 5 events, 5 records, 3 Class I
  2. Siemens Healthcare Diagnostics, Inc. · 5 events, 5 records
  3. Ortho-Clinical Diagnostics · 4 events, 6 records
  4. Siemens Medical Solutions USA, Inc · 4 events, 5 records
  5. Synthes, Inc. · 4 events, 4 records
  6. Biomet, Inc. · 3 events, 6 records
  7. CooperSurgical, Inc. · 3 events, 3 records
  8. Edwards Lifesciences, LLC · 3 events, 3 records

FDA root cause

  1. Nonconforming Material/Component · 53
  2. Under Investigation by firm · 24
  3. Device Design · 21
  4. Process control · 17
  5. Software design · 14
  6. Labeling mix-ups · 8
  7. Error in labeling · 7
  8. Other · 6

Class I recalls (6)

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

Class II recalls (174)

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.