Skip to content

Medical device recalls: March 2025

The FDA posted 244 medical device recall records in March 2025, from 77 recall events by 59 companies. 23 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 · 6 events, 39 records
  2. Baxter Healthcare Corporation · 4 events, 18 records, 2 Class I
  3. Beckman Coulter, Inc. · 4 events, 4 records
  4. Smiths Medical ASD, Inc. · 3 events, 15 records, 13 Class I
  5. American Contract Systems Inc · 2 events, 33 records
  6. Stryker Corporation · 2 events, 15 records
  7. CareFusion 303, Inc. · 2 events, 3 records, 2 Class I
  8. Microbiologics Inc · 2 events, 2 records

FDA root cause

  1. Process control · 60
  2. Under Investigation by firm · 59
  3. Software design · 31
  4. Device Design · 23
  5. Process change control · 16
  6. Labeling design · 11
  7. Unknown/Undetermined by firm · 9
  8. Packaging process control · 9

Class I recalls (23)

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

Class II recalls (221)

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.