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Medical device recalls: July 2019

The FDA posted 50 medical device recall records in July 2019, from 17 recall events by 15 companies. 13 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 · 3 events, 6 records, 2 Class I
  2. Burlington Medical, LLC · 1 event, 24 records
  3. Datascope Corp. · 1 event, 6 records, 6 Class I
  4. Roche Diagnostics Corporation · 1 event, 2 records
  5. Zevex Incorporated (dba MOOG Medical Devices Group) · 1 event, 2 records
  6. Becton Dickinson & Company · 1 event, 1 record, 1 Class I
  7. CareFusion 303, Inc. · 1 event, 1 record, 1 Class I
  8. Centurion Medical Products Corporation · 1 event, 1 record, 1 Class I

FDA root cause

  1. Under Investigation by firm · 24
  2. Device Design · 8
  3. Use error · 6
  4. Nonconforming Material/Component · 5
  5. Software design · 2
  6. Process control · 2
  7. Error in labeling · 1
  8. Employee error · 1

Class I recalls (13)

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

Class II recalls (35)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Class III recalls (2)

Using the device is not likely to cause health problems, but it violates FDA rules.

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.