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Medical device recalls: January 2020

The FDA posted 136 medical device recall records in January 2020, from 26 recall events by 22 companies. 9 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. GE Healthcare, LLC · 4 events, 14 records, 9 Class I
  2. Siemens Healthcare Diagnostics, Inc. · 2 events, 5 records
  3. Arrow International Inc · 1 event, 49 records
  4. Cardinal Health · 1 event, 39 records
  5. Flexicare Medical Ltd. · 1 event, 4 records
  6. Isopure Corp · 1 event, 3 records
  7. Siemens Healthcare Diagnostics, Inc · 1 event, 3 records
  8. Stryker Instruments Div. of Stryker Corporation · 1 event, 3 records

FDA root cause

  1. Other · 50
  2. Vendor change control · 39
  3. Under Investigation by firm · 12
  4. Process control · 12
  5. Nonconforming Material/Component · 8
  6. Software design · 6
  7. Device Design · 3
  8. Use error · 1

Class I recalls (9)

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

Class II recalls (127)

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.