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Medical device recalls: December 2017

The FDA posted 13 medical device recall records in December 2017, from 9 recall events by 8 companies. 3 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. Philips Electronics North America Corporation · 2 events, 2 records
  2. Stryker Neurovascular · 1 event, 3 records
  3. BioMerieux SA · 1 event, 2 records
  4. Physio-Control, Inc. · 1 event, 2 records, 2 Class I
  5. Euro Diagnostica AB · 1 event, 1 record
  6. Maquet · 1 event, 1 record
  7. Medacta Usa Inc · 1 event, 1 record
  8. Sterilmed Inc · 1 event, 1 record, 1 Class I

FDA root cause

  1. Process control · 3
  2. Labeling Change Control · 3
  3. Under Investigation by firm · 2
  4. Software design · 1
  5. Nonconforming Material/Component · 1
  6. Incorrect or no expiration date · 1
  7. Error in labeling · 1
  8. Device Design · 1

Class I recalls (3)

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

Class II recalls (9)

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.