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Medical device recalls: October 2015

The FDA posted 163 medical device recall records in October 2015, from 57 recall events by 46 companies.

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. Siemens Medical Solutions USA, Inc · 4 events, 6 records
  2. Synthes (USA) Products LLC · 4 events, 4 records
  3. Resource Optimization & Innovation Llc · 2 events, 85 records
  4. Toshiba American Medical Systems Inc · 2 events, 7 records
  5. Beckman Coulter Inc. · 2 events, 3 records
  6. Elekta, Inc. · 2 events, 2 records
  7. Encore Medical, Lp · 2 events, 2 records
  8. ConforMIS, Inc. · 1 event, 11 records

FDA root cause

  1. Process control · 87
  2. Device Design · 14
  3. Process design · 12
  4. Packaging · 10
  5. Software design · 6
  6. Radiation Control for Health and Safety Act · 6
  7. Package design/selection · 5
  8. Nonconforming Material/Component · 3

Class II recalls (161)

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.