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Medical device recalls: November 2016

The FDA posted 248 medical device recall records in November 2016, from 46 recall events by 38 companies. 6 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. Siemens Medical Solutions USA, Inc · 3 events, 7 records
  2. Mevion Medical Systems, Inc. · 3 events, 3 records
  3. Synthes (USA) Products LLC · 2 events, 9 records
  4. Merit Medical Systems, Inc. · 2 events, 6 records
  5. Roche Diagnostics Operations, Inc. · 2 events, 3 records
  6. Greatbatch Medical · 2 events, 2 records, 1 Class I
  7. ICU Medical, Inc. · 1 event, 162 records
  8. Stryker Neurovascular · 1 event, 15 records

FDA root cause

  1. Device Design · 170
  2. Employee error · 16
  3. Process control · 15
  4. Nonconforming Material/Component · 14
  5. Under Investigation by firm · 9
  6. Software design · 4
  7. Software in the Use Environment · 3
  8. Packaging · 3

Class I recalls (6)

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

Class II recalls (240)

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.