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Medical device recalls: August 2019

The FDA posted 48 medical device recall records in August 2019, from 18 recall events by 16 companies. 16 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. Luminex Corporation · 2 events, 8 records
  2. Medline Industries Inc · 2 events, 2 records, 2 Class I
  3. Philips Medical Systems (Cleveland) Inc · 1 event, 9 records
  4. St Jude Medical Inc. · 1 event, 6 records, 6 Class I
  5. Edwards Lifesciences, LLC · 1 event, 4 records, 4 Class I
  6. Siemens Medical Solutions USA, Inc · 1 event, 4 records
  7. Geistlich Pharma North America, Inc. · 1 event, 3 records
  8. Fenwal Inc · 1 event, 2 records, 2 Class I

FDA root cause

  1. Other · 19
  2. Process control · 16
  3. Under Investigation by firm · 7
  4. Software design · 3
  5. Nonconforming Material/Component · 3

Class I recalls (16)

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

Class II recalls (32)

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.