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Medical device recalls: March 2023

The FDA posted 113 medical device recall records in March 2023, from 68 recall events by 58 companies. 6 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. Datascope Corp. · 5 events, 12 records, 4 Class I
  2. St. Jude Medical · 2 events, 7 records
  3. CooperVision, Inc. · 2 events, 3 records
  4. Brainlab AG · 2 events, 2 records
  5. CareFusion 303, Inc. · 2 events, 2 records
  6. Intuitive Surgical, Inc. · 2 events, 2 records
  7. Preat Corp · 2 events, 2 records
  8. Becton Dickinson & Company · 1 event, 8 records

FDA root cause

  1. Under Investigation by firm · 36
  2. Device Design · 15
  3. Process control · 11
  4. Software design · 8
  5. Labeling Change Control · 6
  6. Use error · 4
  7. Employee error · 4
  8. Equipment maintenance · 3

Class I recalls (6)

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

Class II recalls (106)

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.