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Medical device recalls: October 2016

The FDA posted 60 medical device recall records in October 2016, from 43 recall events by 38 companies. 10 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 Biomet, Inc. · 4 events, 5 records
  2. Teleflex Medical · 2 events, 3 records, 1 Class I
  3. Randox Laboratories Ltd. · 2 events, 2 records
  4. Synergetics Inc · 1 event, 4 records
  5. Toshiba American Medical Systems Inc · 1 event, 4 records
  6. Trumpf Medical Systems, Inc. · 1 event, 4 records
  7. St Jude Medical Inc. · 1 event, 3 records, 3 Class I
  8. Vascular Solutions, Inc. · 1 event, 3 records, 3 Class I

FDA root cause

  1. Nonconforming Material/Component · 10
  2. Device Design · 10
  3. Process control · 7
  4. Software design · 6
  5. Under Investigation by firm · 5
  6. Other · 5
  7. Mixed-up of materials/components · 4
  8. Use error · 2

Class I recalls (10)

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

Class II recalls (49)

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

Class III recalls (1)

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.