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Medical device recalls: June 2016

The FDA posted 110 medical device recall records in June 2016, from 40 recall events by 35 companies. 12 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, 8 records
  2. Siemens Medical Solutions USA Inc. · 2 events, 37 records
  3. Alcon Research, Ltd. · 2 events, 2 records
  4. Pentax Medical Company · 1 event, 16 records
  5. Carefusion 211 Inc dba Carefusion · 1 event, 12 records, 12 Class I
  6. B. Braun Medical, Inc. · 1 event, 2 records
  7. GE Healthcare, LLC · 1 event, 2 records
  8. Nephron Pharmaceuticals Corp. · 1 event, 2 records

FDA root cause

  1. Nonconforming Material/Component · 39
  2. Device Design · 21
  3. Under Investigation by firm · 20
  4. Process control · 9
  5. Process design · 5
  6. Software design · 4
  7. Radiation Control for Health and Safety Act · 2
  8. Other · 2

Class I recalls (12)

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

Class II recalls (98)

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

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.