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Medical device recalls: November 2022

The FDA posted 176 medical device recall records in November 2022, from 66 recall events by 65 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. Baxter Healthcare Corporation · 2 events, 7 records
  2. ROi CPS LLC · 1 event, 40 records
  3. 3M Healthcare Business · 1 event, 18 records
  4. Carefusion 2200 Inc · 1 event, 17 records
  5. MEDLINE INDUSTRIES, LP - Northfield · 1 event, 13 records
  6. Cardinal Health 200, LLC · 1 event, 8 records
  7. Becton, Dickinson and Company, BD Biosciences · 1 event, 3 records
  8. Boston Scientific Corporation · 1 event, 3 records

FDA root cause

  1. Component change control · 60
  2. Under Investigation by firm · 57
  3. Pending · 9
  4. Nonconforming Material/Component · 9
  5. Device Design · 9
  6. Other · 7
  7. Process control · 6
  8. Employee error · 3

Class I recalls (4)

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

Class II recalls (171)

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

Class III recalls (1)

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.