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Medical device recalls: December 2014

The FDA posted 638 medical device recall records in December 2014, from 133 recall events by 107 companies. 201 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. Philips Medical Systems, Inc. · 4 events, 4 records, 1 Class I
  2. Siemens Healthcare Diagnostics, Inc. · 3 events, 4 records
  3. Teleflex Medical · 3 events, 4 records
  4. Integra LifeSciences Corp. · 3 events, 3 records
  5. Philips Medical Systems (Cleveland) Inc · 3 events, 3 records
  6. Siemens Medical Solutions USA, Inc · 3 events, 3 records
  7. Zimmer, Inc. · 3 events, 3 records
  8. Stryker Endoscopy · 2 events, 210 records

FDA root cause

  1. Error in labeling · 209
  2. Packaging · 180
  3. Device Design · 54
  4. Process control · 33
  5. No Marketing Application · 32
  6. Nonconforming Material/Component · 27
  7. Software design · 19
  8. Software Design Change · 15

Class I recalls (201)

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

Class II recalls (430)

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.