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Medical device recalls: September 2025

The FDA posted 189 medical device recall records in September 2025, from 82 recall events by 72 companies. 44 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. Philips Medical Systems Nederland B.V. · 4 events, 17 records
  2. Boston Scientific Corporation · 3 events, 7 records
  3. Siemens Medical Solutions USA, Inc · 2 events, 16 records, 15 Class I
  4. Medline Industries, LP · 2 events, 7 records, 7 Class I
  5. Abbott Point Of Care Inc. · 2 events, 4 records
  6. Maquet Cardiovascular, LLC · 2 events, 4 records
  7. Boston Scientific Neuromodulation Corporation · 2 events, 2 records
  8. Philips North America Llc · 1 event, 10 records

FDA root cause

  1. Under Investigation by firm · 75
  2. Device Design · 31
  3. Process control · 21
  4. Software design · 13
  5. No Marketing Application · 7
  6. Component design/selection · 7
  7. Incorrect or no expiration date · 6
  8. Component change control · 5

Class I recalls (44)

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

Class II recalls (144)

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.