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Medical device recalls: December 2024

The FDA posted 213 medical device recall records in December 2024, from 68 recall events by 53 companies. 15 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 · 5 events, 67 records
  2. Siemens Healthcare Diagnostics, Inc. · 4 events, 11 records
  3. Micro-X Ltd. · 3 events, 3 records
  4. Noah Medical · 3 events, 3 records
  5. Becton Dickinson & Co. · 2 events, 14 records
  6. Encore Medical, LP · 2 events, 2 records
  7. Olympus Corporation of the Americas · 2 events, 2 records
  8. Philips North America Llc · 2 events, 2 records

FDA root cause

  1. Nonconforming Material/Component · 46
  2. Under Investigation by firm · 43
  3. Software design · 31
  4. Process control · 21
  5. Device Design · 18
  6. Component design/selection · 18
  7. Radiation Control for Health and Safety Act · 10
  8. Process change control · 6

Class I recalls (15)

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

Class II recalls (198)

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

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.