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Medical device recalls: February 2025

The FDA posted 184 medical device recall records in February 2025, from 71 recall events by 57 companies. 29 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. CareFusion 303, Inc. · 7 events, 13 records
  2. Philips Medical Systems Nederland B.V. · 3 events, 40 records, 20 Class I
  3. Physio-Control, Inc. · 3 events, 3 records
  4. Augustine Temperature Management, LLC · 2 events, 5 records
  5. MEDLINE INDUSTRIES, LP - Northfield · 2 events, 3 records
  6. Beckman Coulter, Inc. · 2 events, 2 records
  7. Scientia Vascular, Inc. · 2 events, 2 records
  8. Tyber Medical · 1 event, 18 records

FDA root cause

  1. Under Investigation by firm · 50
  2. Device Design · 39
  3. Process control · 29
  4. Software design · 21
  5. Material/Component Contamination · 12
  6. Nonconforming Material/Component · 7
  7. Radiation Control for Health and Safety Act · 5
  8. Process change control · 4

Class I recalls (29)

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

Class II recalls (155)

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

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.