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Medical device recalls: August 2025

The FDA posted 251 medical device recall records in August 2025, from 71 recall events by 60 companies. 38 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. Boston Scientific Corporation · 4 events, 16 records, 15 Class I
  2. Baxter Healthcare Corporation · 3 events, 5 records, 4 Class I
  3. CareFusion 303, Inc. · 3 events, 4 records, 2 Class I
  4. MEDLINE INDUSTRIES, LP - Northfield · 3 events, 3 records, 1 Class I
  5. GE Medical Systems, LLC · 2 events, 24 records
  6. Beckman Coulter, Inc. · 2 events, 7 records
  7. Philips Ultrasound, Inc · 1 event, 69 records
  8. AVID Medical, Inc. · 1 event, 24 records

FDA root cause

  1. Device Design · 79
  2. Under Investigation by firm · 65
  3. Equipment maintenance · 25
  4. Process control · 23
  5. Nonconforming Material/Component · 11
  6. Labeling design · 8
  7. Process design · 6
  8. Labeling Change Control · 5

Class I recalls (38)

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

Class II recalls (140)

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

Class III recalls (73)

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.