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Medical device recalls: January 2019

The FDA posted 22 medical device recall records in January 2019, from 6 recall events by 6 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. Draeger Medical, Inc. · 1 event, 9 records, 9 Class I
  2. Edwards Lifesciences, LLC · 1 event, 4 records, 4 Class I
  3. Fetzer Medical GmbH & Co. KG · 1 event, 4 records
  4. West Pharma. Services Il, Ltd · 1 event, 3 records, 3 Class I
  5. GE Healthcare, LLC · 1 event, 1 record
  6. Swissray Medical AG · 1 event, 1 record

FDA root cause

  1. Process design · 9
  2. Device Design · 8
  3. Nonconforming Material/Component · 4
  4. Component design/selection · 1

Class I recalls (16)

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

Class II recalls (6)

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.