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Medical device recalls: April 2022

The FDA posted 44 medical device recall records in April 2022, from 19 recall events by 17 companies. 6 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. GE Healthcare, LLC · 3 events, 7 records
  2. Siemens Medical Solutions USA, Inc · 1 event, 14 records
  3. Respironics California, LLC · 1 event, 3 records, 3 Class I
  4. restor3d Inc. · 1 event, 3 records
  5. ROi CPS LLC · 1 event, 3 records
  6. Abbott Molecular, Inc. · 1 event, 2 records
  7. Philips North America LLC · 1 event, 2 records
  8. Baxter Healthcare Corporation · 1 event, 1 record

FDA root cause

  1. Device Design · 22
  2. Under Investigation by firm · 8
  3. Nonconforming Material/Component · 4
  4. Process change control · 3
  5. Radiation Control for Health and Safety Act · 2
  6. Process control · 2
  7. Software Design Change · 1
  8. Other · 1

Class I recalls (6)

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

Class II recalls (38)

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.