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Medical device recalls: September 2024

The FDA posted 426 medical device recall records in September 2024, from 113 recall events by 88 companies. 24 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 - Northfield · 6 events, 110 records
  2. Siemens Healthcare Diagnostics, Inc. · 5 events, 12 records
  3. Smiths Medical ASD Inc. · 3 events, 7 records, 7 Class I
  4. Philips Medical Systems Nederland B.V. · 3 events, 6 records
  5. Boston Scientific Corporation · 2 events, 36 records
  6. Philips North America Llc · 2 events, 14 records
  7. B Braun Medical Inc · 2 events, 8 records, 1 Class I
  8. Philips North America · 2 events, 7 records

FDA root cause

  1. Under Investigation by firm · 191
  2. Process control · 75
  3. Device Design · 36
  4. Nonconforming Material/Component · 28
  5. Software design · 13
  6. Other · 12
  7. Incorrect or no expiration date · 12
  8. Process design · 9

Class I recalls (24)

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

Class II recalls (399)

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

Class III recalls (3)

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.