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Medical device recalls: May 2024

The FDA posted 346 medical device recall records in May 2024, from 87 recall events by 69 companies. 61 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 · 5 events, 36 records
  2. MEDLINE INDUSTRIES, LP - Northfield · 5 events, 8 records, 1 Class I
  3. Stryker Neurovascular · 3 events, 12 records
  4. Cardinal Health 200, LLC · 2 events, 6 records
  5. Fresenius Medical Care Holdings, Inc. · 2 events, 6 records
  6. Philips Medical Systems Nederland B.V. · 2 events, 4 records
  7. Philips Respironics, Inc. · 2 events, 4 records, 4 Class I
  8. Baxter Healthcare Corporation · 2 events, 2 records

FDA root cause

  1. Under Investigation by firm · 126
  2. No Marketing Application · 88
  3. Process control · 39
  4. Device Design · 29
  5. Software design · 21
  6. Component design/selection · 12
  7. Process design · 11
  8. Nonconforming Material/Component · 5

Class I recalls (61)

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

Class II recalls (284)

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.