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Medical device recalls: April 2025

The FDA posted 200 medical device recall records in April 2025, from 78 recall events by 57 companies. 42 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. MEDLINE INDUSTRIES, LP - Northfield · 5 events, 45 records, 5 Class I
  2. CareFusion 303, Inc. · 4 events, 4 records
  3. Philips North America Llc · 3 events, 6 records
  4. Medtronic Neuromodulation · 3 events, 3 records
  5. Baxter Healthcare Corporation · 2 events, 10 records
  6. Abbott Diagnostics Scarborough, Inc. · 2 events, 6 records
  7. Defibtech, LLC · 2 events, 5 records
  8. Belmont Instrument LLC · 2 events, 4 records

FDA root cause

  1. Under Investigation by firm · 76
  2. Device Design · 43
  3. Process control · 23
  4. Software design · 9
  5. Process change control · 9
  6. Process design · 7
  7. Nonconforming Material/Component · 7
  8. Software change control · 6

Class I recalls (42)

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

Class II recalls (158)

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.