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Medical device recalls: January 2024

The FDA posted 317 medical device recall records in January 2024, from 109 recall events by 86 companies. 14 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 · 6 events, 19 records
  2. Philips North America · 5 events, 13 records
  3. Randox Laboratories Ltd. · 4 events, 4 records
  4. Philips Medical Systems Nederland B.V. · 3 events, 3 records
  5. Baxter Healthcare Corporation · 2 events, 17 records
  6. Abiomed, Inc. · 2 events, 11 records
  7. Maquet Cardiovascular, LLC · 2 events, 4 records, 2 Class I
  8. Bard Peripheral Vascular Inc · 2 events, 2 records

FDA root cause

  1. Nonconforming Material/Component · 80
  2. Under Investigation by firm · 71
  3. Process control · 58
  4. Device Design · 18
  5. Equipment maintenance · 16
  6. Software design · 13
  7. Packaging change control · 13
  8. Other · 8

Class I recalls (14)

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

Class II recalls (296)

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

Class III recalls (7)

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.