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Medical device recalls: April 2023

The FDA posted 147 medical device recall records in April 2023, from 73 recall events by 65 companies. 9 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, 5 records
  2. Baxter Healthcare Corporation · 3 events, 3 records
  3. Medtronic Sofamor Danek USA Inc · 2 events, 17 records
  4. Stryker Corporation · 2 events, 7 records
  5. Philips Respironics, Inc. · 2 events, 4 records, 4 Class I
  6. Covidien · 2 events, 2 records, 1 Class I
  7. Coloplast Manufacturing US, LLC · 1 event, 17 records
  8. ROi CPS LLC · 1 event, 8 records

FDA root cause

  1. Under Investigation by firm · 43
  2. Process control · 33
  3. Process change control · 22
  4. Nonconforming Material/Component · 10
  5. Device Design · 9
  6. Software design · 8
  7. Employee error · 5
  8. Process design · 2

Class I recalls (9)

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

Class II recalls (137)

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.