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Medical device recalls: January 2018

The FDA posted 31 medical device recall records in January 2018, from 23 recall events by 20 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. Exactech, Inc. · 3 events, 4 records
  2. Edwards Lifesciences, LLC · 2 events, 2 records, 1 Class I
  3. Vyaire Medical · 1 event, 4 records, 4 Class I
  4. Abbott Laboratories, Inc · 1 event, 3 records
  5. Fujifilm Medical Systems U.S.A., Inc. · 1 event, 2 records
  6. Repro-Med Systems, Inc. · 1 event, 2 records
  7. Baxter Healthcare Corporation · 1 event, 1 record
  8. C.R. Bard, Inc. · 1 event, 1 record

FDA root cause

  1. Device Design · 8
  2. Under Investigation by firm · 5
  3. Process control · 5
  4. Nonconforming Material/Component · 3
  5. Employee error · 3
  6. Other · 2
  7. Software in the Use Environment · 1
  8. Software design · 1

Class I recalls (6)

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

Class II recalls (25)

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

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.