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Medical device recalls: August 2026

The FDA posted 218 medical device recall records in August 2026, from 100 recall events by 76 companies. 7 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 · 7 events, 52 records
  2. Philips Medical Systems Nederland B.V. · 4 events, 6 records
  3. Siemens Healthcare Diagnostics, Inc. · 4 events, 5 records
  4. AVID Medical, Inc. · 3 events, 11 records
  5. GE Medical Systems Information Technologies Inc · 3 events, 6 records
  6. American Contract Systems Inc · 2 events, 6 records
  7. United Orthopedic Corp. · 2 events, 6 records
  8. Beckman Coulter Inc. · 2 events, 4 records

FDA root cause

  1. Nonconforming Material/Component · 54
  2. Under Investigation by firm · 47
  3. Process control · 17
  4. Device Design · 17
  5. Software design · 15
  6. Process change control · 14
  7. Labeling Change Control · 9
  8. Process design · 8

Class I recalls (7)

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

Class II recalls (207)

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

Class III recalls (4)

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.