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Medical device recalls: February 2024

The FDA posted 288 medical device recall records in February 2024, from 96 recall events by 73 companies. 106 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. Olympus Corporation of the Americas · 5 events, 14 records
  2. Philips North America · 4 events, 20 records, 3 Class I
  3. Philips Medical Systems Nederland B.V. · 4 events, 8 records
  4. MEDLINE INDUSTRIES, LP - Northfield · 3 events, 57 records, 49 Class I
  5. Maquet Medical Systems USA · 3 events, 5 records
  6. BioFire Diagnostics, LLC · 3 events, 4 records
  7. Abiomed, Inc. · 3 events, 3 records, 1 Class I
  8. Cardinal Health 200, LLC · 2 events, 23 records, 23 Class I

FDA root cause

  1. Process control · 81
  2. Nonconforming Material/Component · 77
  3. Under Investigation by firm · 32
  4. Software design · 18
  5. Process change control · 14
  6. Device Design · 11
  7. Error in labeling · 7
  8. Process design · 6

Class I recalls (106)

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

Class II recalls (179)

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

Class III recalls (3)

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.