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Medical device recalls: September 2021

The FDA posted 40 medical device recall records in September 2021, from 12 recall events by 11 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. GE Healthcare, LLC · 2 events, 3 records
  2. C.R. Bard Inc · 1 event, 21 records
  3. Cordis Corporation · 1 event, 5 records, 5 Class I
  4. Siemens Medical Solutions USA, Inc · 1 event, 3 records
  5. Athena Medical Products Inc · 1 event, 2 records, 2 Class I
  6. Armstrong Medical Services Limited · 1 event, 1 record, 1 Class I
  7. Copan Italia · 1 event, 1 record
  8. Deroyal Industries, Inc. Lafollette · 1 event, 1 record, 1 Class I

FDA root cause

  1. Packaging change control · 21
  2. Device Design · 6
  3. Software design · 5
  4. Process control · 4
  5. Nonconforming Material/Component · 2
  6. Vendor change control · 1
  7. Under Investigation by firm · 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 (30)

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.