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Medical device recalls: June 2026

The FDA posted 341 medical device recall records in June 2026, from 98 recall events by 81 companies. 59 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 · 6 events, 107 records, 4 Class I
  2. Abiomed, Inc. · 3 events, 6 records, 6 Class I
  3. Philips North America Llc · 3 events, 4 records
  4. Philips Medical Systems Nederland B.V. · 2 events, 10 records
  5. GE Medical Systems, LLC · 2 events, 8 records
  6. Zimmer, Inc. · 2 events, 6 records
  7. Boston Scientific Neuromodulation Corporation · 2 events, 3 records
  8. Steris Corporation · 2 events, 3 records

FDA root cause

  1. Nonconforming Material/Component · 87
  2. Process control · 59
  3. Under Investigation by firm · 57
  4. Material/Component Contamination · 24
  5. Process change control · 22
  6. Component design/selection · 21
  7. No Marketing Application · 16
  8. Device Design · 14

Class I recalls (59)

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

Class II recalls (282)

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.