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Medical device recalls: June 2020

The FDA posted 57 medical device recall records in June 2020, from 21 recall events by 19 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 Healthcare Diagnostics, Inc. · 2 events, 8 records
  2. GE Healthcare, LLC · 2 events, 3 records
  3. Stryker GmbH · 1 event, 15 records
  4. Arrow International Inc · 1 event, 10 records, 10 Class I
  5. Beckman Coulter Inc. · 1 event, 6 records
  6. Cook Inc. · 1 event, 2 records
  7. Abbott Laboratories · 1 event, 1 record
  8. Codan US Corporation · 1 event, 1 record

FDA root cause

  1. Process control · 19
  2. Component design/selection · 11
  3. Device Design · 10
  4. Other · 8
  5. Software Design Change · 2
  6. Employee error · 2
  7. Under Investigation by firm · 1
  8. Software design · 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 (46)

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.