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Medical device recalls: September 2016

The FDA posted 131 medical device recall records in September 2016, from 59 recall events by 50 companies. 13 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 Medical Solutions USA, Inc · 3 events, 6 records
  2. Mentor Texas, LP. · 2 events, 4 records
  3. Hologic, Inc · 2 events, 3 records
  4. Sorin Group USA, Inc. · 2 events, 3 records
  5. Stryker Howmedica Osteonics Corp. · 2 events, 3 records
  6. Alcon Research, Ltd. · 2 events, 2 records
  7. Beckman Coulter Inc. · 2 events, 2 records
  8. Merge Healthcare, Inc. · 2 events, 2 records

FDA root cause

  1. Process control · 47
  2. Nonconforming Material/Component · 15
  3. Software design · 12
  4. Use error · 11
  5. Device Design · 9
  6. Under Investigation by firm · 6
  7. Employee error · 6
  8. Labeling mix-ups · 4

Class I recalls (13)

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

Class II recalls (112)

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

Class III recalls (6)

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.