Skip to content

Medical device recalls: December 2025

The FDA posted 254 medical device recall records in December 2025, from 70 recall events by 59 companies. 12 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 · 4 events, 11 records
  2. Fresenius Kabi USA, LLC · 3 events, 3 records, 2 Class I
  3. Philips North America Llc · 2 events, 24 records
  4. Draeger, Inc. · 2 events, 6 records, 6 Class I
  5. Datascope Corp. · 2 events, 4 records
  6. Microbiologics Inc · 2 events, 4 records
  7. ICU Medical, Inc. · 2 events, 2 records
  8. Philips Ultrasound, LLC · 2 events, 2 records

FDA root cause

  1. No Marketing Application · 99
  2. Process design · 26
  3. Under Investigation by firm · 25
  4. Use error · 22
  5. Process control · 15
  6. Device Design · 11
  7. Labeling design · 8
  8. Software design · 7

Class I recalls (12)

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

Class II recalls (233)

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

Class III recalls (9)

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.