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Medical device recalls: January 2021

The FDA posted 67 medical device recall records in January 2021, from 14 recall events by 12 companies. 12 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. Fresenius Medical Care Holdings, Inc. · 2 events, 30 records
  2. Boston Scientific Corporation · 2 events, 7 records, 7 Class I
  3. Respironics California, LLC · 1 event, 16 records
  4. Penumbra Inc. · 1 event, 4 records, 4 Class I
  5. Ortho-Clinical Diagnostics, Inc. · 1 event, 2 records
  6. Roche Diagnostics Operations, Inc. · 1 event, 2 records
  7. Biomet, Inc. · 1 event, 1 record
  8. Hill-Rom, Inc. · 1 event, 1 record, 1 Class I

FDA root cause

  1. Under Investigation by firm · 31
  2. Device Design · 28
  3. Process design · 4
  4. Software design · 2
  5. Radiation Control for Health and Safety Act · 1
  6. Employee error · 1

Class I recalls (12)

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

Class II recalls (55)

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.