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Medical device recalls: July 2016

The FDA posted 107 medical device recall records in July 2016, from 50 recall events by 41 companies. 4 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. Synthes (USA) Products LLC · 4 events, 20 records
  2. Merge Healthcare, Inc. · 3 events, 3 records
  3. Arrow International Inc · 2 events, 3 records
  4. Stryker Instruments Div. of Stryker Corporation · 2 events, 3 records
  5. Beckman Coulter Inc. · 2 events, 2 records
  6. Toshiba American Medical Systems Inc · 2 events, 2 records
  7. Stryker Neurovascular · 1 event, 28 records
  8. Pentax Medical Company · 1 event, 6 records

FDA root cause

  1. Process change control · 29
  2. Labeling False and Misleading · 18
  3. Device Design · 13
  4. Software design · 9
  5. Nonconforming Material/Component · 7
  6. Process control · 6
  7. Under Investigation by firm · 5
  8. Radiation Control for Health and Safety Act · 3

Class I recalls (4)

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

Class II recalls (99)

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

Class III recalls (4)

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.