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Medical device recalls: April 2026

The FDA posted 328 medical device recall records in April 2026, from 81 recall events by 66 companies. 36 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 · 7 events, 104 records, 19 Class I
  2. Beckman Coulter, Inc. · 3 events, 3 records
  3. Olympus Corporation of the Americas · 2 events, 16 records
  4. Integra LifeSciences Corp. (NeuroSciences) · 2 events, 6 records
  5. Beta Bionics, Inc. · 2 events, 2 records
  6. Foundation Medicine, Inc. · 2 events, 2 records
  7. Siemens Medical Solutions USA, Inc · 2 events, 2 records
  8. Uvlizer c/o RAIS INTERNATIONAL LLC · 2 events, 2 records

FDA root cause

  1. Under Investigation by firm · 128
  2. Device Design · 44
  3. Nonconforming Material/Component · 28
  4. No Marketing Application · 23
  5. Incorrect or no expiration date · 19
  6. Component change control · 18
  7. Process control · 17
  8. Process change control · 17

Class I recalls (36)

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

Class II recalls (290)

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.