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Medical device recalls: June 2025

The FDA posted 156 medical device recall records in June 2025, from 84 recall events by 71 companies. 19 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. Beckman Coulter, Inc. · 4 events, 4 records
  2. Siemens Medical Solutions USA, Inc · 2 events, 6 records
  3. Dexcom, Inc. · 2 events, 5 records, 4 Class I
  4. Olympus Corporation of the Americas · 2 events, 5 records
  5. Integra LifeSciences Corp. (NeuroSciences) · 2 events, 4 records, 4 Class I
  6. MEDLINE INDUSTRIES, LP - Northfield · 2 events, 4 records
  7. Ortho-Clinical Diagnostics, Inc. · 2 events, 4 records
  8. Stryker GmbH · 2 events, 3 records

FDA root cause

  1. Under Investigation by firm · 36
  2. Process control · 28
  3. Software design · 15
  4. Process design · 12
  5. Nonconforming Material/Component · 10
  6. Component design/selection · 10
  7. Software design (manufacturing process) · 6
  8. Radiation Control for Health and Safety Act · 6

Class I recalls (19)

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

Class II recalls (135)

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

Class III recalls (2)

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.