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Medical device recalls: January 2026

The FDA posted 214 medical device recall records in January 2026, from 80 recall events by 63 companies. 17 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 · 5 events, 40 records, 6 Class I
  2. Philips Medical Systems Nederland B.V. · 4 events, 19 records
  3. ICU Medical, Inc. · 3 events, 5 records
  4. Philips North America · 2 events, 14 records
  5. Canon Medical System, USA, INC. · 2 events, 6 records
  6. Ge Medical Systems Israel, Functional Imaging · 2 events, 5 records
  7. Beckman Coulter, Inc. · 2 events, 3 records
  8. Siemens Medical Solutions USA, Inc · 2 events, 3 records

FDA root cause

  1. Under Investigation by firm · 43
  2. Nonconforming Material/Component · 41
  3. Device Design · 33
  4. Software design · 26
  5. Process control · 22
  6. Other · 16
  7. Storage · 5
  8. Process design · 5

Class I recalls (17)

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

Class II recalls (197)

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.