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Medical device recalls: March 2013

The FDA posted 124 medical device recall records in March 2013, from 96 recall events by 72 companies. 5 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. Synthes USA HQ, Inc. · 6 events, 8 records
  2. GE Healthcare, LLC · 4 events, 4 records
  3. Medtronic Inc. Cardiac Rhythm Disease Management · 3 events, 3 records
  4. Philips Medical Systems (Cleveland) Inc · 3 events, 3 records
  5. Siemens Healthcare Diagnostics, Inc. · 3 events, 3 records
  6. Siemens Medical Solutions USA, Inc · 3 events, 3 records
  7. Cooper Surgical, Inc. · 2 events, 10 records
  8. Biomerieux Inc · 2 events, 4 records

FDA root cause

  1. Software design · 19
  2. Process control · 15
  3. Nonconforming Material/Component · 15
  4. Device Design · 14
  5. Packaging process control · 10
  6. Package design/selection · 10
  7. Employee error · 6
  8. Mixed-up of materials/components · 5

Class I recalls (5)

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

Class II recalls (102)

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.