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Medical device recalls: December 2023

The FDA posted 181 medical device recall records in December 2023, from 79 recall events by 63 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. Siemens Healthcare Diagnostics Inc · 3 events, 7 records
  2. Atrium Medical Corporation · 3 events, 4 records
  3. Maquet Medical Systems USA · 3 events, 3 records, 1 Class I
  4. Integra LifeSciences Corp. · 2 events, 10 records, 1 Class I
  5. MEDLINE INDUSTRIES, LP - Northfield · 2 events, 10 records, 3 Class I
  6. Ortho-Clinical Diagnostics, Inc. · 2 events, 6 records
  7. CardioQuip, LLC · 2 events, 4 records
  8. Abbott Laboratories · 2 events, 2 records

FDA root cause

  1. Under Investigation by firm · 48
  2. Process control · 40
  3. Device Design · 28
  4. Software design (manufacturing process) · 11
  5. Labeling design · 11
  6. Component design/selection · 10
  7. Software design · 9
  8. Nonconforming Material/Component · 4

Class I recalls (24)

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

Class II recalls (155)

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.