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Medical device recalls: October 2023

The FDA posted 181 medical device recall records in October 2023, from 67 recall events by 56 companies. 27 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. Cardinal Health 200, LLC · 3 events, 17 records, 6 Class I
  2. Smiths Medical ASD Inc. · 3 events, 8 records
  3. Fresenius Medical Care Holdings, Inc. · 2 events, 11 records, 11 Class I
  4. GE Healthcare · 2 events, 5 records
  5. Encore Medical, LP · 2 events, 3 records
  6. Olympus Corporation of the Americas · 2 events, 3 records, 1 Class I
  7. Beckman Coulter, Inc. · 2 events, 2 records
  8. Coapt LLC · 2 events, 2 records

FDA root cause

  1. Other · 30
  2. Employee error · 23
  3. Under Investigation by firm · 22
  4. Device Design · 20
  5. Process control · 18
  6. Software design · 11
  7. Material/Component Contamination · 11
  8. Vendor change control · 6

Class I recalls (27)

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

Class II recalls (154)

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.