Skip to content

Medical device recalls: August 2013

The FDA posted 277 medical device recall records in August 2013, from 130 recall events by 82 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 · 9 events, 11 records
  2. SpineFrontier, Inc. · 9 events, 9 records
  3. Zimmer, Inc. · 6 events, 57 records
  4. Siemens Medical Solutions USA, Inc · 6 events, 6 records
  5. Synthes USA HQ, Inc. · 4 events, 4 records
  6. Terumo Cardiovascular Systems Corporation · 3 events, 6 records
  7. Medtronic Inc. Cardiac Rhythm Disease Management · 3 events, 5 records
  8. Beckman Coulter Inc. · 3 events, 3 records

FDA root cause

  1. Device Design · 71
  2. Labeling design · 49
  3. Software design · 24
  4. Software change control · 15
  5. Package design/selection · 15
  6. Nonconforming Material/Component · 14
  7. Process control · 13
  8. Material/Component Contamination · 13

Class I recalls (23)

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

Class II recalls (247)

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

Class III recalls (7)

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.