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Medical device recalls: April 2020

The FDA posted 118 medical device recall records in April 2020, from 22 recall events by 20 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. Beckman Coulter Inc. · 2 events, 3 records
  2. Philips North America, LLC · 2 events, 3 records
  3. Biomet, Inc. · 1 event, 33 records
  4. K2M, Inc · 1 event, 24 records
  5. Boston Scientific · 1 event, 12 records
  6. Welch Allyn, Inc/Mortara · 1 event, 10 records
  7. Canon Medical System, USA, INC. · 1 event, 8 records
  8. Boston Scientific Neuromodulation Corporation · 1 event, 5 records

FDA root cause

  1. Process control · 37
  2. Device Design · 35
  3. Component change control · 12
  4. Software design · 11
  5. Process design · 5
  6. Error in labeling · 5
  7. Radiation Control for Health and Safety Act · 4
  8. Nonconforming Material/Component · 2

Class I recalls (2)

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

Class II recalls (116)

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.