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Medical device recalls: March 2019

The FDA posted 14 medical device recall records in March 2019, from 8 recall events by 8 companies. 3 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. Getinge US Sales LLC · 1 event, 4 records
  2. Beckman Coulter Inc. · 1 event, 2 records
  3. CTL Medical Corporation · 1 event, 2 records
  4. Reckitt Benckiser LLC · 1 event, 2 records
  5. Cook Inc. · 1 event, 1 record, 1 Class I
  6. Maquet Cardiovascular Us Sales, Llc · 1 event, 1 record, 1 Class I
  7. Microbiologics Inc · 1 event, 1 record
  8. Rvo 2.0, Inc · 1 event, 1 record, 1 Class I

FDA root cause

  1. Under Investigation by firm · 4
  2. Other · 4
  3. Process control · 2
  4. Nonconforming Material/Component · 2
  5. Unknown/Undetermined by firm · 1
  6. Error in labeling · 1

Class I recalls (3)

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

Class II recalls (11)

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.