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Medical device recalls: July 2017

The FDA posted 31 medical device recall records in July 2017, from 12 recall events by 12 companies.

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. Icu · 1 event, 9 records
  2. Sorin Group USA, Inc. · 1 event, 6 records
  3. Medtronic Perfusion Systems · 1 event, 5 records
  4. Cardinal Health 200, LLC · 1 event, 2 records
  5. Kentec Medical Inc · 1 event, 2 records
  6. Atrium Medical Corporation · 1 event, 1 record
  7. Beckman Coulter Inc · 1 event, 1 record
  8. Mallinckrodt Manufacturing LLC · 1 event, 1 record

FDA root cause

  1. Other · 10
  2. Device Design · 7
  3. Packaging process control · 5
  4. Process control · 2
  5. Mixed-up of materials/components · 2
  6. Under Investigation by firm · 1
  7. Software design · 1
  8. Packaging · 1

Class II recalls (30)

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.