Skip to content

Medical device recalls: August 2024

The FDA posted 487 medical device recall records in August 2024, from 82 recall events by 61 companies. 43 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 · 7 events, 81 records, 3 Class I
  2. Beckman Coulter, Inc. · 4 events, 4 records
  3. CareFusion 303, Inc. · 3 events, 22 records
  4. Baxter Healthcare Corporation · 3 events, 4 records
  5. Covidien · 3 events, 4 records, 3 Class I
  6. Smiths Medical ASD Inc. · 2 events, 31 records, 31 Class I
  7. Olympus Corporation of the Americas · 2 events, 6 records
  8. BioFire Diagnostics, LLC · 2 events, 3 records

FDA root cause

  1. No Marketing Application · 182
  2. Under Investigation by firm · 154
  3. Process control · 52
  4. Device Design · 43
  5. Nonconforming Material/Component · 16
  6. Software design · 13
  7. Error in labeling · 6
  8. Package design/selection · 5

Class I recalls (43)

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

Class II recalls (442)

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

Class III recalls (2)

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.