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Medical device recalls: February 2015

The FDA posted 189 medical device recall records in February 2015, from 87 recall events by 65 companies. 12 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. Teleflex Medical · 4 events, 18 records, 1 Class I
  2. Intuitive Surgical, Inc. · 4 events, 6 records
  3. Siemens Medical Solutions USA, Inc. · 3 events, 4 records
  4. Biomet Spine, LLC · 3 events, 3 records
  5. Zimmer, Inc. · 3 events, 3 records
  6. Hospira Inc. · 2 events, 6 records, 5 Class I
  7. Invacare Corporation · 2 events, 4 records
  8. Biomet, Inc. · 2 events, 3 records

FDA root cause

  1. Packaging · 61
  2. Process control · 20
  3. Device Design · 17
  4. Material/Component Contamination · 16
  5. Software design · 8
  6. Under Investigation by firm · 6
  7. Component design/selection · 6
  8. Packaging process control · 5

Class I recalls (12)

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

Class II recalls (174)

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.