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Medical device recalls: January 2017

The FDA posted 100 medical device recall records in January 2017, from 65 recall events by 48 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. Endologix · 7 events, 8 records
  2. The Binding Site Group, Ltd. · 5 events, 11 records
  3. GE OEC Medical Systems, Inc · 2 events, 5 records
  4. Bard Access Systems · 2 events, 4 records
  5. Beckman Coulter Inc. · 2 events, 3 records
  6. ICU Medical, Inc. · 2 events, 2 records
  7. Implant Direct Sybron Manufacturing, LLC · 2 events, 2 records
  8. Roche Diagnostics Operations, Inc. · 2 events, 2 records

FDA root cause

  1. Device Design · 23
  2. Nonconforming Material/Component · 15
  3. Under Investigation by firm · 13
  4. Process control · 7
  5. Software design · 5
  6. Use error · 4
  7. Component design/selection · 4
  8. Mixed-up of materials/components · 3

Class I recalls (7)

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

Class II recalls (92)

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

Class III recalls (1)

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.