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Medical device recalls: June 2013

The FDA posted 177 medical device recall records in June 2013, from 95 recall events by 75 companies. 23 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. GE Healthcare, LLC · 5 events, 5 records
  2. Baxter Healthcare Corp. · 3 events, 10 records
  3. Medtronic Neuromodulation · 3 events, 8 records, 8 Class I
  4. Bard Peripheral Vascular Inc · 3 events, 6 records
  5. American Optisurgical Inc · 3 events, 3 records
  6. Biomet, Inc. · 3 events, 3 records
  7. Hill-Rom, Inc. · 2 events, 5 records
  8. Prism Medical Services USA · 2 events, 5 records

FDA root cause

  1. Nonconforming Material/Component · 40
  2. Device Design · 35
  3. Under Investigation by firm · 15
  4. Software design · 12
  5. Process control · 12
  6. Use error · 8
  7. Employee error · 7
  8. No Marketing Application · 6

Class I recalls (23)

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

Class II recalls (148)

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

Class III recalls (6)

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.