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Medical device recalls: August 2016

The FDA posted 221 medical device recall records in August 2016, from 49 recall events by 44 companies. 13 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. Cook Inc. · 2 events, 15 records, 1 Class I
  2. Intuitive Surgical, Inc. · 2 events, 6 records
  3. Merge Healthcare, Inc. · 2 events, 2 records
  4. Stryker Instruments Div. of Stryker Corporation · 2 events, 2 records
  5. Teleflex Medical · 2 events, 2 records
  6. Biomet 3i, LLC · 1 event, 119 records
  7. Alere San Diego, Inc. · 1 event, 9 records, 9 Class I
  8. Tecan US, Inc. · 1 event, 7 records

FDA root cause

  1. Packaging · 120
  2. Nonconforming Material/Component · 21
  3. Unknown/Undetermined by firm · 14
  4. Software design · 11
  5. Other · 11
  6. Under Investigation by firm · 9
  7. Process design · 7
  8. Process control · 6

Class I recalls (13)

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

Class II recalls (205)

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

Class III recalls (3)

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.