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Medical device recalls: December 2015

The FDA posted 108 medical device recall records in December 2015, from 65 recall events by 57 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 Medical Systems (Cleveland) Inc · 3 events, 8 records
  2. Becton Dickinson & Company · 2 events, 6 records
  3. Zimmer, Inc. · 2 events, 4 records
  4. Merz North America, Inc. · 2 events, 3 records
  5. CareFusion 303, Inc. · 2 events, 2 records
  6. Draeger Medical, Inc. · 2 events, 2 records, 2 Class I
  7. Siemens Medical Solutions USA, Inc · 2 events, 2 records
  8. LeMaitre Vascular, Inc. · 1 event, 13 records

FDA root cause

  1. Software design · 16
  2. Process change control · 13
  3. Packaging process control · 13
  4. Nonconforming Material/Component · 13
  5. Process control · 11
  6. Under Investigation by firm · 10
  7. Other · 7
  8. Employee error · 7

Class I recalls (9)

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

Class II recalls (98)

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

Class III recalls (1)

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.