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Medical device recalls: November 2018

The FDA posted 29 medical device recall records in November 2018, from 17 recall events by 15 companies. 12 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. GE Healthcare, LLC · 3 events, 7 records, 4 Class I
  2. Baxter Healthcare Corporation · 1 event, 5 records
  3. Aroa Biosurgery · 1 event, 3 records
  4. Beckman Coulter Inc. · 1 event, 2 records, 2 Class I
  5. Maquet Cardiovascular Us Sales, Llc · 1 event, 2 records, 2 Class I
  6. Becton Dickinson & Co. · 1 event, 1 record
  7. Collagen Matrix, Inc. · 1 event, 1 record
  8. Howmedica Osteonics Corp. · 1 event, 1 record

FDA root cause

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

Class I recalls (12)

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

Class II recalls (16)

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.