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Medical device recalls: September 2014

The FDA posted 175 medical device recall records in September 2014, from 109 recall events by 84 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. Philips Medical Systems (Cleveland) Inc · 5 events, 5 records
  2. Siemens Medical Solutions USA, Inc · 5 events, 5 records
  3. Zimmer, Inc. · 3 events, 11 records
  4. Siemens Healthcare Diagnostics · 3 events, 5 records
  5. Siemens Healthcare Diagnostics, Inc. · 3 events, 3 records
  6. Fresenius Medical Care Holdings, Inc. · 2 events, 7 records
  7. Nanosphere, Inc. · 2 events, 7 records
  8. Bio-Detek, Inc. · 2 events, 4 records

FDA root cause

  1. Device Design · 34
  2. Nonconforming Material/Component · 23
  3. Software design · 19
  4. Labeling design · 15
  5. Process control · 14
  6. Component design/selection · 10
  7. No Marketing Application · 9
  8. Under Investigation by firm · 8

Class I recalls (6)

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

Class II recalls (166)

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

Class III recalls (3)

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.