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Medical device recalls: April 2014

The FDA posted 216 medical device recall records in April 2014, from 91 recall events by 68 companies. 7 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. Teleflex Medical · 4 events, 9 records
  2. Philips Medical Systems, Inc. · 4 events, 4 records
  3. Ortho-Clinical Diagnostics · 3 events, 4 records
  4. GE Healthcare, LLC · 3 events, 3 records
  5. Philips Medical Systems (Cleveland) Inc · 3 events, 3 records
  6. Merit Medical Systems, Inc. · 2 events, 4 records
  7. Siemens Healthcare Diagnostics · 2 events, 4 records
  8. Arrow International Inc · 2 events, 2 records

FDA root cause

  1. No Marketing Application · 84
  2. Packaging process control · 19
  3. Nonconforming Material/Component · 18
  4. Process control · 12
  5. Device Design · 12
  6. Under Investigation by firm · 11
  7. Software design · 10
  8. Other · 10

Class I recalls (7)

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

Class II recalls (207)

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

Class III recalls (2)

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.