Skip to content

Medical device recalls: February 2018

The FDA posted 68 medical device recall records in February 2018, from 28 recall events by 24 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. Aesculap Implant Systems LLC · 3 events, 3 records
  2. DePuy Orthopaedics, Inc. · 2 events, 3 records
  3. Philips Electronics North America Corporation · 2 events, 3 records
  4. Arrow International Inc · 1 event, 12 records
  5. Ventana Medical Systems Inc · 1 event, 12 records, 12 Class I
  6. Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · 1 event, 8 records, 8 Class I
  7. Beaver-Visitec International Inc. · 1 event, 5 records
  8. Philips Medical Systems (Cleveland) Inc · 1 event, 5 records

FDA root cause

  1. Process control · 31
  2. Process design · 8
  3. Under Investigation by firm · 7
  4. Device Design · 7
  5. Nonconforming Material/Component · 3
  6. Mixed-up of materials/components · 3
  7. No Marketing Application · 2
  8. Use error · 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 (45)

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.