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Medical device recalls: May 2026

The FDA posted 231 medical device recall records in May 2026, from 64 recall events by 52 companies. 55 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 · 4 events, 61 records, 18 Class I
  2. Philips Medical Systems Nederland B.V. · 4 events, 7 records
  3. Covidien LLC · 2 events, 4 records
  4. Medtronic Neuromodulation · 2 events, 3 records
  5. Abiomed, Inc. · 2 events, 2 records, 2 Class I
  6. BioFire Diagnostics, LLC · 2 events, 2 records
  7. Fresenius Kabi USA, LLC · 2 events, 2 records, 1 Class I
  8. Intuitive Surgical, Inc. · 2 events, 2 records, 1 Class I

FDA root cause

  1. Process control · 87
  2. Under Investigation by firm · 60
  3. Software design · 16
  4. Nonconforming Material/Component · 16
  5. Component design/selection · 10
  6. Packaging process control · 9
  7. Device Design · 9
  8. No Marketing Application · 7

Class I recalls (55)

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

Class II recalls (176)

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.