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Medical device recalls: September 2015

The FDA posted 302 medical device recall records in September 2015, from 80 recall events by 70 companies. 4 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. Intuitive Surgical, Inc. · 3 events, 11 records
  2. Covidien LLC · 2 events, 16 records
  3. Fujifilm Medical Systems U.S.A., Inc. · 2 events, 3 records
  4. Beckman Coulter Inc. · 2 events, 2 records
  5. Biomet Spine, LLC · 2 events, 2 records
  6. Leica Microsystems, Inc. · 2 events, 2 records
  7. Pointe Scientific, Inc. · 2 events, 2 records
  8. Siemens Medical Solutions USA, Inc · 2 events, 2 records

FDA root cause

  1. Packaging · 172
  2. Device Design · 26
  3. Nonconforming Material/Component · 19
  4. Process control · 16
  5. Packaging process control · 15
  6. Software Manufacturing/Software Deployment · 10
  7. Software design · 7
  8. Under Investigation by firm · 6

Class I recalls (4)

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

Class II recalls (294)

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.