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Medical device recalls: October 2018

The FDA posted 32 medical device recall records in October 2018, from 14 recall events by 14 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. Nakanishi Inc. · 1 event, 8 records
  2. Alcon Research, LTD. · 1 event, 4 records, 4 Class I
  3. Endologix · 1 event, 4 records, 4 Class I
  4. GE Medical Systems, SCS · 1 event, 3 records
  5. Smith & Nephew, Inc. · 1 event, 3 records
  6. Maquet Datascope Corp - Cardiac Assist Division · 1 event, 2 records, 2 Class I
  7. Beckman Coulter Inc. · 1 event, 1 record
  8. BioFire Diagnostics, LLC · 1 event, 1 record

FDA root cause

  1. Device Design · 20
  2. Other · 4
  3. Process control · 3
  4. Material/Component Contamination · 2
  5. Unknown/Undetermined by firm · 1
  6. Under Investigation by firm · 1
  7. Software design · 1

Class I recalls (10)

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

Class II recalls (22)

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.