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Medical device recalls: December 2021

The FDA posted 22 medical device recall records in December 2021, from 6 recall events by 6 companies. 19 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. Covidien Llc · 1 event, 16 records, 16 Class I
  2. Datascope Corp. · 1 event, 2 records, 2 Class I
  3. Cardiovascular Systems Inc · 1 event, 1 record, 1 Class I
  4. NuVasive Specialized Orthopedics, Inc. · 1 event, 1 record
  5. Olympus Corporation of the Americas · 1 event, 1 record
  6. ROi CPS LLC · 1 event, 1 record

FDA root cause

  1. Reprocessing Controls · 16
  2. Device Design · 4
  3. Under Investigation by firm · 1
  4. Process control · 1

Class I recalls (19)

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.