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Medical device recalls: May 2025

The FDA posted 189 medical device recall records in May 2025, from 74 recall events by 57 companies. 27 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 · 4 events, 16 records, 3 Class I
  2. Onkos Surgical, Inc. · 3 events, 9 records
  3. Smiths Medical ASD, Inc. · 3 events, 5 records, 5 Class I
  4. Baxter Healthcare Corporation · 3 events, 4 records, 3 Class I
  5. Foundation Medicine, Inc. · 3 events, 3 records
  6. Philips North America Llc · 2 events, 19 records
  7. Philips Medical Systems Nederland B.V. · 2 events, 15 records
  8. Cook Incorporated · 2 events, 3 records

FDA root cause

  1. Process control · 38
  2. Under Investigation by firm · 34
  3. Storage · 32
  4. Software design · 26
  5. Nonconforming Material/Component · 10
  6. Device Design · 10
  7. Packaging change control · 6
  8. Package design/selection · 6

Class I recalls (27)

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

Class II recalls (161)

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.