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Medical device recalls: July 2014

The FDA posted 187 medical device recall records in July 2014, from 111 recall events by 84 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. Teleflex Medical · 4 events, 19 records
  2. GE Healthcare, LLC · 4 events, 5 records, 1 Class I
  3. Terumo Cardiovascular Systems Corporation · 3 events, 18 records
  4. Intuitive Surgical, Inc. · 3 events, 14 records
  5. Zimmer, Inc. · 3 events, 5 records
  6. Integra LifeSciences Corp. · 3 events, 3 records
  7. Siemens Medical Solutions USA, Inc · 3 events, 3 records
  8. Siemens Medical Solutions USA, Inc. · 2 events, 3 records

FDA root cause

  1. Device Design · 42
  2. Process control · 34
  3. Nonconforming Material/Component · 19
  4. Packaging change control · 17
  5. Software design · 12
  6. Process design · 8
  7. Under Investigation by firm · 5
  8. Package design/selection · 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 (176)

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

Class III recalls (6)

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.