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Medical device recalls: April 2021

The FDA posted 26 medical device recall records in April 2021, from 11 recall events by 11 companies. 2 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. Smiths Medical ASD Inc. · 1 event, 12 records
  2. Nuvasive Specialized Orthopedics Inc · 1 event, 3 records
  3. Datascope Corp. · 1 event, 2 records
  4. Tenacore LLC · 1 event, 2 records, 2 Class I
  5. Alcon Research, LLC · 1 event, 1 record
  6. Arrow International Inc · 1 event, 1 record
  7. Howmedica Osteonics Corp. · 1 event, 1 record
  8. Integra LifeSciences Corp. · 1 event, 1 record

FDA root cause

  1. Process control · 12
  2. Software design · 3
  3. Device Design · 3
  4. Component design/selection · 2
  5. Vendor change control · 1
  6. Under Investigation by firm · 1
  7. Process design · 1
  8. Nonconforming Material/Component · 1

Class I recalls (2)

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

Class II recalls (21)

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

Class III recalls (3)

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.