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Medical device recalls: April 2024

The FDA posted 223 medical device recall records in April 2024, from 81 recall events by 70 companies. 28 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. Covidien, LP · 3 events, 10 records
  2. Baxter Healthcare Corporation · 3 events, 7 records
  3. Philips North America Llc · 2 events, 42 records
  4. Zimmer, Inc. · 2 events, 22 records
  5. Olympus Corporation of the Americas · 2 events, 4 records
  6. SonarMed Inc · 2 events, 4 records, 4 Class I
  7. MEDLINE INDUSTRIES, LP - Northfield · 2 events, 3 records
  8. 3M Company - Health Care Business · 2 events, 2 records

FDA root cause

  1. Under Investigation by firm · 75
  2. Process design · 52
  3. Device Design · 30
  4. Process control · 26
  5. Labeling design · 9
  6. Nonconforming Material/Component · 8
  7. Software design · 4
  8. Process change control · 4

Class I recalls (28)

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

Class II recalls (194)

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.