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Medical device recalls: April 2018

The FDA posted 43 medical device recall records in April 2018, from 20 recall events by 18 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. Philips Electronics North America Corporation · 2 events, 14 records
  2. Teleflex Medical Europe Ltd · 2 events, 5 records
  3. C.R. Bard, Inc. · 1 event, 3 records
  4. Datascope Corporation · 1 event, 3 records
  5. Terumo Cardiovascular Systems Corporation · 1 event, 3 records
  6. Cook Inc. · 1 event, 2 records
  7. DePuy Orthopaedics, Inc. · 1 event, 2 records
  8. Bard Brachytherapy, Inc. · 1 event, 1 record

FDA root cause

  1. Nonconforming Material/Component · 14
  2. Process control · 6
  3. Error in labeling · 4
  4. Employee error · 4
  5. Device Design · 4
  6. Labeling design · 3
  7. Other · 2
  8. Under Investigation by firm · 1

Class II recalls (42)

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.