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Medical device recalls: November 2023

The FDA posted 229 medical device recall records in November 2023, from 76 recall events by 64 companies. 16 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. Philips North America Llc · 3 events, 20 records
  2. Aizu Olympus Co., Ltd. · 2 events, 27 records
  3. Stryker Corporation · 2 events, 20 records
  4. Edwards Lifesciences, LLC · 2 events, 7 records
  5. Olympus Corporation of the Americas · 2 events, 7 records, 6 Class I
  6. Atrium Medical Corporation · 2 events, 4 records
  7. Covidien · 2 events, 3 records, 1 Class I
  8. Encore Medical, LP · 2 events, 3 records

FDA root cause

  1. Under Investigation by firm · 105
  2. Device Design · 40
  3. Process control · 24
  4. Process change control · 12
  5. Storage · 10
  6. Error in labeling · 7
  7. Software design · 6
  8. Nonconforming Material/Component · 6

Class I recalls (16)

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

Class II recalls (212)

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.