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Medical device recalls: June 2024

The FDA posted 212 medical device recall records in June 2024, from 70 recall events by 62 companies. 12 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, 7 records, 3 Class I
  2. MEDLINE INDUSTRIES, LP - Northfield · 2 events, 10 records
  3. Exactech, Inc. · 2 events, 5 records
  4. Integra LifeSciences Corp. · 2 events, 4 records
  5. Baxter Healthcare Corporation · 2 events, 2 records, 1 Class I
  6. Olympus Corporation of the Americas · 2 events, 2 records
  7. Ortho-Clinical Diagnostics, Inc. · 2 events, 2 records
  8. Atrium Medical Corporation · 1 event, 68 records

FDA root cause

  1. Equipment maintenance · 68
  2. Under Investigation by firm · 37
  3. Nonconforming Material/Component · 28
  4. Process control · 24
  5. Device Design · 19
  6. Software design · 6
  7. Component design/selection · 6
  8. No Marketing Application · 5

Class I recalls (12)

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

Class II recalls (196)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Class III recalls (4)

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.