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Medical device recalls: July 2026

The FDA posted 241 medical device recall records in July 2026, from 102 recall events by 76 companies. 42 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. Boston Scientific Corporation · 7 events, 25 records
  2. Medline Industries, LP · 7 events, 24 records, 6 Class I
  3. Olympus Corporation of the Americas · 4 events, 7 records
  4. Windstone Medical Packaging, Inc. · 3 events, 16 records, 4 Class I
  5. AVID Medical, Inc. · 3 events, 5 records, 3 Class I
  6. Argon Medical Devices, Inc · 2 events, 8 records, 6 Class I
  7. Medtronic Perfusion Systems · 2 events, 8 records
  8. Baxter Healthcare Corporation · 2 events, 5 records, 4 Class I

FDA root cause

  1. Under Investigation by firm · 68
  2. Nonconforming Material/Component · 33
  3. Process control · 23
  4. Material/Component Contamination · 23
  5. Device Design · 20
  6. Process change control · 14
  7. Software Design Change · 12
  8. Package design/selection · 12

Class I recalls (42)

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

Class II recalls (199)

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.