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Medical device recalls: June 2019

The FDA posted 57 medical device recall records in June 2019, from 17 recall events by 14 companies. 21 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. Maquet Cardiovascular Us Sales, Llc · 2 events, 14 records
  2. GE Healthcare, LLC · 2 events, 11 records
  3. Cook Inc. · 2 events, 4 records, 3 Class I
  4. Teleflex Medical · 1 event, 8 records, 8 Class I
  5. OriGen Biomedical, Inc. · 1 event, 6 records, 6 Class I
  6. Medtronic Inc · 1 event, 5 records
  7. Vyaire Medical · 1 event, 2 records, 2 Class I
  8. Becton Dickinson & Company · 1 event, 1 record, 1 Class I

FDA root cause

  1. Device Design · 23
  2. Process control · 16
  3. Radiation Control for Health and Safety Act · 6
  4. Under Investigation by firm · 5
  5. Labeling mix-ups · 5
  6. Software design · 1
  7. Labeling False and Misleading · 1

Class I recalls (21)

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 (1)

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.