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Medical device recalls: September 2026

The FDA posted 255 medical device recall records in September 2026, from 96 recall events by 70 companies. 30 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 · 5 events, 19 records, 7 Class I
  2. AVID Medical, Inc. · 5 events, 9 records, 6 Class I
  3. Olympus Corporation of the Americas · 4 events, 8 records
  4. Cardinal Health 200, LLC · 3 events, 18 records
  5. Philips North America Llc · 3 events, 17 records
  6. Fresenius Medical Care Renal Therapies Group, LLC · 3 events, 8 records
  7. Boston Scientific Corporation · 3 events, 5 records, 1 Class I
  8. Philips North America · 2 events, 14 records

FDA root cause

  1. Software design · 48
  2. Under Investigation by firm · 42
  3. Process control · 35
  4. Nonconforming Material/Component · 35
  5. Process change control · 28
  6. Device Design · 26
  7. Packaging process control · 7
  8. Material/Component Contamination · 6

Class I recalls (30)

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

Class II recalls (224)

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

Class III recalls (1)

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.