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Medical device recalls: November 2024

The FDA posted 289 medical device recall records in November 2024, from 91 recall events by 70 companies. 32 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, 23 records
  2. Baxter Healthcare Corporation · 5 events, 29 records, 11 Class I
  3. Olympus Corporation of the Americas · 3 events, 3 records
  4. Boston Scientific Corporation · 2 events, 9 records, 7 Class I
  5. Abbott Medical · 2 events, 7 records
  6. Smiths Medical ASD, Inc. · 2 events, 4 records
  7. Cook Incorporated · 2 events, 3 records
  8. Bard Peripheral Vascular Inc · 2 events, 2 records

FDA root cause

  1. Process control · 84
  2. Under Investigation by firm · 82
  3. Device Design · 26
  4. Nonconforming Material/Component · 19
  5. Process change control · 16
  6. Use error · 15
  7. Software design · 11
  8. Component design/selection · 8

Class I recalls (32)

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

Class II recalls (251)

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

Class III recalls (6)

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.