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Medical device recalls: January 2025

The FDA posted 280 medical device recall records in January 2025, from 91 recall events by 71 companies. 28 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, 9 records, 4 Class I
  2. Olympus Corporation of the Americas · 3 events, 13 records, 1 Class I
  3. GE Medical Systems, LLC · 3 events, 9 records
  4. CareFusion 303, Inc. · 3 events, 8 records
  5. Stryker Corporation · 3 events, 4 records
  6. Intuitive Surgical, Inc. · 2 events, 39 records
  7. Boston Scientific Corporation · 2 events, 20 records, 6 Class I
  8. Karl Storz Endoscopy · 2 events, 15 records

FDA root cause

  1. Under Investigation by firm · 64
  2. Process control · 45
  3. Process change control · 43
  4. Device Design · 30
  5. Nonconforming Material/Component · 20
  6. Labeling Change Control · 19
  7. Package design/selection · 13
  8. Process design · 9

Class I recalls (28)

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

Class II recalls (251)

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.