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Medical device recalls: February 2016

The FDA posted 136 medical device recall records in February 2016, from 66 recall events by 54 companies. 9 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 Electronics North America Corporation · 4 events, 7 records
  2. Cook Inc. · 3 events, 6 records, 5 Class I
  3. Bard Peripheral Vascular Inc · 2 events, 3 records
  4. Draeger Medical, Inc. · 2 events, 3 records, 3 Class I
  5. Siemens Healthcare Diagnostics, Inc. · 2 events, 3 records
  6. C.R. Bard, Inc. · 2 events, 2 records
  7. Leica Microsystems, Inc. · 2 events, 2 records
  8. Siemens Medical Solutions USA, Inc · 2 events, 2 records

FDA root cause

  1. Process control · 36
  2. Under Investigation by firm · 27
  3. Labeling Change Control · 14
  4. Device Design · 14
  5. Software design · 9
  6. Nonconforming Material/Component · 8
  7. Error in labeling · 6
  8. Component design/selection · 4

Class I recalls (9)

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

Class II recalls (124)

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.