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Medical device recalls: July 2025

The FDA posted 174 medical device recall records in July 2025, from 73 recall events by 66 companies. 21 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 · 2 events, 5 records
  2. Ortho-Clinical Diagnostics, Inc. · 2 events, 5 records
  3. Baxter Healthcare Corporation · 2 events, 4 records, 4 Class I
  4. Encore Medical, LP · 2 events, 4 records
  5. Medtronic, Inc. · 2 events, 4 records
  6. Microbiologics Inc · 2 events, 3 records
  7. Philips Medical Systems Nederland B.V. · 2 events, 2 records
  8. Philips Ultrasound, Inc · 1 event, 21 records

FDA root cause

  1. Process control · 42
  2. Under Investigation by firm · 41
  3. Device Design · 33
  4. Software design · 14
  5. Packaging change control · 14
  6. Radiation Control for Health and Safety Act · 6
  7. Process change control · 6
  8. Other · 4

Class I recalls (21)

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

Class II recalls (148)

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

Class III recalls (5)

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.