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Medical device recalls: November 2025

The FDA posted 307 medical device recall records in November 2025, from 83 recall events by 72 companies. 20 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, 6 records, 1 Class I
  2. Medline Industries, LP · 4 events, 42 records, 10 Class I
  3. Medtronic Perfusion Systems · 3 events, 3 records
  4. Integra LifeSciences Corp. (NeuroSciences) · 2 events, 3 records, 2 Class I
  5. Beckman Coulter Inc. · 2 events, 2 records
  6. B Braun Medical Inc · 1 event, 116 records
  7. ASP Global, LLC. dba Anatomy Supply Partners, LLC. · 1 event, 24 records
  8. B-K Medical A/S · 1 event, 6 records

FDA root cause

  1. Process control · 140
  2. Under Investigation by firm · 60
  3. Process change control · 29
  4. Device Design · 28
  5. Nonconforming Material/Component · 14
  6. Component change control · 6
  7. Software design · 5
  8. Release of Material/Component prior to receiving test results · 3

Class I recalls (20)

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

Class II recalls (285)

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

Class III recalls (2)

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.