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Medical device recalls: December 2019

The FDA posted 36 medical device recall records in December 2019, from 20 recall events by 20 companies. 14 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. Roche Diabetes Care, Inc. · 1 event, 6 records
  2. Cook Inc. · 1 event, 4 records, 4 Class I
  3. GE Healthcare, LLC · 1 event, 4 records, 4 Class I
  4. Galemed Corporation · 1 event, 3 records, 3 Class I
  5. Bio-Signal Group Corp. · 1 event, 2 records
  6. Diagnostica Stago, Inc. · 1 event, 2 records
  7. Theralase Inc. · 1 event, 2 records
  8. Ameditech Inc · 1 event, 1 record

FDA root cause

  1. Device Design · 16
  2. Process control · 11
  3. Error in labeling · 2
  4. Software design · 1
  5. Reprocessing Controls · 1
  6. Nonconforming Material/Component · 1
  7. Material/Component Contamination · 1
  8. Labeling mix-ups · 1

Class I recalls (14)

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

Class II recalls (19)

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

Class III recalls (3)

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.