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Medical device recalls: March 2022

The FDA posted 15 medical device recall records in March 2022, from 10 recall events by 8 companies. 4 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. Celltrion USA Inc · 3 events, 3 records, 2 Class I
  2. CellEra LLC · 1 event, 5 records
  3. ev3 Inc. · 1 event, 2 records, 2 Class I
  4. bioMerieux, Inc. · 1 event, 1 record
  5. GE Healthcare, LLC · 1 event, 1 record
  6. Hobbs Medical, Inc. · 1 event, 1 record
  7. MEDLINE INDUSTRIES, LP - Northfield · 1 event, 1 record
  8. Stryker Corporation · 1 event, 1 record

FDA root cause

  1. Labeling Change Control · 5
  2. Labeling design · 2
  3. Under Investigation by firm · 1
  4. Software in the Use Environment · 1
  5. Software design · 1
  6. Process control · 1
  7. Nonconforming Material/Component · 1
  8. No Marketing Application · 1

Class I recalls (4)

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

Class II recalls (6)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Class III recalls (5)

Using the device is not likely to cause health problems, but it violates FDA rules.

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.