Skip to content

Medical device recalls: April 2013

The FDA posted 162 medical device recall records in April 2013, from 120 recall events by 78 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. GE Healthcare, LLC · 11 events, 11 records, 1 Class I
  2. Siemens Healthcare Diagnostics, Inc. · 4 events, 6 records
  3. Toshiba American Medical Systems Inc · 4 events, 4 records
  4. Siemens Medical Solutions USA, Inc · 3 events, 11 records
  5. Hospira Inc. · 3 events, 6 records, 4 Class I
  6. Ortho-Clinical Diagnostics · 3 events, 5 records
  7. Edwards Lifesciences, LLC · 3 events, 4 records
  8. Advanced Sterilization Products · 3 events, 3 records

FDA root cause

  1. Device Design · 28
  2. Nonconforming Material/Component · 21
  3. Software design · 20
  4. Process control · 14
  5. Software design (manufacturing process) · 9
  6. Labeling False and Misleading · 9
  7. Process design · 7
  8. No Marketing Application · 7

Class I recalls (12)

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

Class II recalls (133)

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

Class III recalls (17)

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.