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Medical device recalls: January 2022

The FDA posted 23 medical device recall records in January 2022, from 11 recall events by 8 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. Philips North America Llc · 3 events, 6 records
  2. Microbiologics Inc · 2 events, 2 records
  3. GE Healthcare, LLC · 1 event, 7 records
  4. Baxter Healthcare Corporation · 1 event, 2 records, 2 Class I
  5. ev3 Inc. · 1 event, 2 records, 2 Class I
  6. Philips Respironics, Inc. · 1 event, 2 records, 2 Class I
  7. Covidien Llc · 1 event, 1 record
  8. Siemens Medical Solutions USA, Inc · 1 event, 1 record

FDA root cause

  1. Device Design · 11
  2. No Marketing Application · 5
  3. Mixed-up of materials/components · 2
  4. Labeling mix-ups · 2
  5. Labeling design · 2
  6. Software design · 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 (15)

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

Class III recalls (2)

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.