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Medical device recalls: October 2021

The FDA posted 42 medical device recall records in October 2021, from 12 recall events by 10 companies. 7 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 · 2 events, 11 records
  2. Datascope Corp. · 2 events, 3 records, 1 Class I
  3. Exactech, Inc. · 1 event, 9 records
  4. Abbott Molecular, Inc. · 1 event, 5 records, 5 Class I
  5. CardioQuip, LLC · 1 event, 4 records
  6. Philips North America LLC · 1 event, 4 records
  7. Medtronic Xomed, Inc. · 1 event, 3 records
  8. Beckman Coulter Inc. · 1 event, 1 record

FDA root cause

  1. Process control · 17
  2. Software design · 10
  3. Device Design · 7
  4. Error in labeling · 4
  5. Other · 1
  6. Nonconforming Material/Component · 1
  7. Equipment maintenance · 1
  8. Component change control · 1

Class I recalls (7)

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

Class II recalls (35)

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.