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Medical device recalls: October 2025

The FDA posted 406 medical device recall records in October 2025, from 98 recall events by 81 companies. 73 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. LeMaitre Vascular, Inc. · 3 events, 3 records
  2. Medline Industries, LP · 3 events, 3 records, 1 Class I
  3. ICU Medical, Inc. · 2 events, 39 records, 1 Class I
  4. Boston Scientific Corporation · 2 events, 34 records, 27 Class I
  5. Baxter Healthcare Corporation · 2 events, 17 records
  6. Philips Medical Systems Nederland B.V. · 2 events, 16 records
  7. B Braun Medical Inc · 2 events, 14 records, 1 Class I
  8. Alcon Research LLC · 2 events, 6 records

FDA root cause

  1. Device Design · 97
  2. Under Investigation by firm · 71
  3. Process control · 70
  4. Other · 36
  5. No Marketing Application · 31
  6. Nonconforming Material/Component · 28
  7. Package design/selection · 26
  8. Software design · 20

Class I recalls (73)

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

Class II recalls (332)

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.