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Medical device recalls: March 2017

The FDA posted 138 medical device recall records in March 2017, from 65 recall events by 49 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. Merge Healthcare, Inc. · 7 events, 7 records
  2. Zimmer Biomet, Inc. · 4 events, 44 records
  3. Siemens Medical Solutions USA, Inc · 4 events, 5 records
  4. BioMerieux SA · 3 events, 14 records
  5. Beckman Coulter Inc. · 2 events, 4 records
  6. Siemens Healthcare Diagnostics, Inc. · 2 events, 2 records
  7. Centurion Medical Products Corporation · 1 event, 7 records
  8. Covidien LLC · 1 event, 7 records

FDA root cause

  1. Packaging · 35
  2. Under Investigation by firm · 12
  3. Storage · 12
  4. Software design · 12
  5. Nonconforming Material/Component · 11
  6. Packaging process control · 9
  7. Device Design · 8
  8. Process design · 7

Class I recalls (4)

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

Class II recalls (132)

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

Class III recalls (2)

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.