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Medical device recalls: February 2017

The FDA posted 191 medical device recall records in February 2017, from 44 recall events by 39 companies. 2 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. Terumo Cardiovascular Systems Corporation · 3 events, 3 records
  2. Becton Dickinson & Co. · 2 events, 2 records
  3. CareFusion 303, Inc. · 2 events, 2 records
  4. Encore Medical, Lp · 2 events, 2 records
  5. Windstone Medical Packaging, Inc. · 1 event, 124 records
  6. Medtronic Advanced Energy, LLC · 1 event, 11 records
  7. Medtronic · 1 event, 5 records
  8. Siemens Medical Solutions USA Inc. · 1 event, 4 records

FDA root cause

  1. Nonconforming Material/Component · 131
  2. Package design/selection · 11
  3. Device Design · 7
  4. Other · 5
  5. Employee error · 5
  6. Under Investigation by firm · 4
  7. Software design · 4
  8. Process control · 4

Class I recalls (2)

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

Class II recalls (184)

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

Class III recalls (5)

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.