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Medical device recalls: November 2021

The FDA posted 8 medical device recall records in November 2021, from 5 recall events by 5 companies. 5 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. Arrow International Inc · 1 event, 4 records, 4 Class I
  2. BioCheck, Inc. · 1 event, 1 record
  3. GE Healthcare, LLC · 1 event, 1 record
  4. Instrumentation Laboratory · 1 event, 1 record
  5. Lumenis, Inc. · 1 event, 1 record, 1 Class I

FDA root cause

  1. Unknown/Undetermined by firm · 4
  2. Under Investigation by firm · 1
  3. Radiation Control for Health and Safety Act · 1
  4. Process control · 1
  5. Component change control · 1

Class I recalls (5)

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

Class II recalls (3)

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.