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Medical device recalls: June 2018

The FDA posted 54 medical device recall records in June 2018, from 18 recall events by 15 companies. 2 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. Zimmer Biomet, Inc. · 4 events, 16 records
  2. Orthofix, Inc · 1 event, 20 records
  3. Randox Laboratories Ltd. · 1 event, 3 records
  4. Becton Dickinson & Company · 1 event, 2 records
  5. Draeger Medical Systems, Inc. · 1 event, 2 records, 2 Class I
  6. Philips Medical Systems Nederlands · 1 event, 2 records
  7. BioMerieux SA · 1 event, 1 record
  8. Datex-Ohmeda, Inc. · 1 event, 1 record

FDA root cause

  1. Device Design · 26
  2. Under Investigation by firm · 22
  3. Nonconforming Material/Component · 2
  4. Vendor change control · 1
  5. Software design · 1
  6. Software change control · 1
  7. Radiation Control for Health and Safety Act · 1

Class I recalls (2)

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

Class II recalls (52)

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.