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Medical device recalls: January 2023

The FDA posted 255 medical device recall records in January 2023, from 69 recall events by 59 companies. 17 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 Medical Solutions USA, Inc · 5 events, 7 records
  2. MEDLINE INDUSTRIES, LP - Northfield · 3 events, 9 records
  3. Biomet, Inc. · 3 events, 4 records
  4. DeRoyal Industries Inc · 2 events, 2 records
  5. Medtronic Navigation, Inc. · 2 events, 2 records
  6. Biomerieux Inc · 1 event, 94 records
  7. Cardinal Health 200, LLC · 1 event, 28 records
  8. Stradis Healthcare · 1 event, 18 records

FDA root cause

  1. Storage · 94
  2. Under Investigation by firm · 40
  3. Process control · 37
  4. Unknown/Undetermined by firm · 28
  5. Device Design · 13
  6. Software design · 7
  7. Process change control · 6
  8. Process design · 5

Class I recalls (17)

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

Class II recalls (236)

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.