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Medical device recalls: March 2020

The FDA posted 50 medical device recall records in March 2020, from 21 recall events by 17 companies. 11 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. Siemens Medical Solutions USA, Inc · 2 events, 4 records
  2. Boston Scientific Corporation · 2 events, 3 records, 1 Class I
  3. Butterfly Network, Inc. · 2 events, 2 records
  4. CME America, LLC · 2 events, 2 records, 2 Class I
  5. Medtronic MiniMed · 1 event, 16 records
  6. CareFusion 303, Inc. · 1 event, 4 records, 4 Class I
  7. Gentell, Inc · 1 event, 4 records
  8. Northgate Technologies, Inc. · 1 event, 3 records

FDA root cause

  1. Device Design · 24
  2. Nonconforming Material/Component · 8
  3. No Marketing Application · 6
  4. Under Investigation by firm · 4
  5. Software design · 4
  6. Process change control · 2
  7. Environmental control · 1
  8. Component design/selection · 1

Class I recalls (11)

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

Class II recalls (39)

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.