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Medical device recalls: July 2024

The FDA posted 209 medical device recall records in July 2024, from 84 recall events by 70 companies. 11 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. Baxter Healthcare Corporation · 4 events, 7 records, 2 Class I
  2. Abbott Medical · 3 events, 17 records
  3. CareFusion 303, Inc. · 3 events, 4 records
  4. Angiodynamics, Inc. · 2 events, 3 records
  5. Boston Scientific Corporation · 2 events, 3 records
  6. Beckman Coulter, Inc. · 2 events, 2 records
  7. Medtronic Neuromodulation · 2 events, 2 records
  8. Ortho-Clinical Diagnostics, Inc. · 2 events, 2 records

FDA root cause

  1. Under Investigation by firm · 60
  2. Process control · 43
  3. Device Design · 17
  4. Component design/selection · 14
  5. Software design · 13
  6. Vendor change control · 12
  7. Nonconforming Material/Component · 6
  8. Employee error · 6

Class I recalls (11)

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

Class II recalls (197)

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.