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Medical device recalls: September 2020

The FDA posted 19 medical device recall records in September 2020, from 9 recall events by 7 companies. 5 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. CareFusion 303, Inc. · 2 events, 3 records, 3 Class I
  2. MicroPort Orthopedics Inc. · 2 events, 3 records, 2 Class I
  3. Stimwave Technologies Inc · 1 event, 6 records
  4. Integra LifeSciences Corp. · 1 event, 3 records
  5. Tosoh Bioscience Inc · 1 event, 2 records
  6. Novarad Corporation · 1 event, 1 record
  7. Siemens Medical Solutions USA, Inc · 1 event, 1 record

FDA root cause

  1. Under Investigation by firm · 8
  2. Mixed-up of materials/components · 3
  3. Reprocessing Controls · 2
  4. Device Design · 2
  5. Software design · 1
  6. Software Design Change · 1
  7. Labeling Change Control · 1
  8. Component design/selection · 1

Class I recalls (5)

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

Class II recalls (14)

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.