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Medical device recalls: October 2024

The FDA posted 281 medical device recall records in October 2024, from 99 recall events by 71 companies. 25 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 · 7 events, 8 records
  2. MEDLINE INDUSTRIES, LP - Northfield · 5 events, 44 records
  3. Beckman Coulter, Inc. · 4 events, 4 records
  4. Integra LifeSciences Corp. · 3 events, 24 records
  5. Smiths Medical ASD Inc. · 3 events, 15 records, 1 Class I
  6. Baxter Healthcare Corporation · 3 events, 11 records, 1 Class I
  7. Medtronic Neuromodulation · 3 events, 3 records
  8. Boston Scientific Corporation · 2 events, 23 records

FDA root cause

  1. Under Investigation by firm · 87
  2. Process control · 44
  3. Device Design · 36
  4. Nonconforming Material/Component · 34
  5. Packaging process control · 16
  6. No Marketing Application · 12
  7. Use error · 10
  8. Software design · 6

Class I recalls (25)

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

Class II recalls (253)

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.