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Medical device recalls: May 2022

The FDA posted 13 medical device recall records in May 2022, from 11 recall events by 11 companies. 7 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. Atrium Medical Corporation · 1 event, 2 records, 2 Class I
  2. Baxter Healthcare Corporation · 1 event, 2 records, 2 Class I
  3. Abbott Vascular · 1 event, 1 record, 1 Class I
  4. ARJOHUNTLEIGH POLSKA Sp. z.o.o. · 1 event, 1 record, 1 Class I
  5. Avanos Medical, Inc. · 1 event, 1 record, 1 Class I
  6. Ion Beam Applications S.A. · 1 event, 1 record
  7. Luminex Corporation · 1 event, 1 record
  8. Medtronic Neuromodulation · 1 event, 1 record

FDA root cause

  1. Device Design · 8
  2. Under Investigation by firm · 4
  3. Software design · 1

Class I recalls (7)

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

Class II recalls (6)

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

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.