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Medical device recalls: October 2026

The FDA posted 150 medical device recall records in October 2026 so far, from 48 recall events by 45 companies. 3 are Class I, the most serious category. 77 have not been classified yet.

Each product in a recall gets its own record, so one recall event can cover several records. FDA recall data on this site is from the file dated Oct 16, 2026; more records for October 2026 may be added later. What recall classes mean.

Companies with the most recall events

  1. Steris Corporation · 3 events, 10 records
  2. Medline Industries, LP · 2 events, 4 records, 2 Class I
  3. ASP Global, LLC. · 1 event, 64 records
  4. AVID Medical, Inc. · 1 event, 15 records
  5. Mindray DS USA, Inc. · 1 event, 8 records
  6. BioFire Diagnostics, LLC · 1 event, 3 records
  7. Jenavalve Technology Inc. · 1 event, 3 records
  8. Beckman Coulter Inc. · 1 event, 2 records

FDA root cause

  1. Under Investigation by firm · 86
  2. Process change control · 20
  3. Labeling design · 10
  4. Process control · 8
  5. Software design · 7
  6. Nonconforming Material/Component · 7
  7. Device Design · 3
  8. Labeling mix-ups · 2

Class I recalls (3)

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

Class II recalls (70)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Not yet classified (77)

The FDA has posted these records but has not published a class for them yet.

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.