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Medical device recalls: November 2014

The FDA posted 93 medical device recall records in November 2014, from 56 recall events by 46 companies. 4 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 Healthcare Diagnostics, Inc. · 3 events, 4 records, 2 Class I
  2. Nidek Inc · 3 events, 3 records
  3. Zimmer, Inc. · 2 events, 3 records
  4. Integra LifeSciences Corp. · 2 events, 2 records
  5. Medacta Usa · 2 events, 2 records
  6. Remel Inc · 2 events, 2 records
  7. Siemens Healthcare Diagnostics, Inc · 2 events, 2 records
  8. Siemens Medical Solutions USA, Inc · 2 events, 2 records

FDA root cause

  1. Labeling design · 24
  2. Process control · 10
  3. Nonconforming Material/Component · 9
  4. Device Design · 9
  5. Software design · 8
  6. Labeling Change Control · 5
  7. Component design/selection · 5
  8. Employee error · 4

Class I recalls (4)

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

Class II recalls (79)

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

Class III recalls (10)

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.