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Medical device recalls: May 2013

The FDA posted 255 medical device recall records in May 2013, from 93 recall events by 79 companies. 22 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. Intuitive Surgical, Inc. · 6 events, 10 records
  2. Becton Dickinson & Co. · 3 events, 6 records
  3. GE Healthcare, LLC · 3 events, 6 records
  4. Karl Storz Endoscopy America Inc · 2 events, 13 records
  5. Alere San Diego, Inc. · 2 events, 2 records
  6. Beckman Coulter Inc. · 2 events, 2 records
  7. DePuy Orthopaedics, Inc. · 2 events, 2 records
  8. Stryker Howmedica Osteonics Corp. · 2 events, 2 records

FDA root cause

  1. Process control · 40
  2. Labeling design · 32
  3. Nonconforming Material/Component · 30
  4. Error in labeling · 23
  5. Packaging process control · 19
  6. Manufacturing material removal · 17
  7. Software design · 15
  8. Packaging · 15

Class I recalls (22)

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

Class II recalls (205)

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

Class III recalls (28)

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.