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Medical device recalls: June 2021

The FDA posted 20 medical device recall records in June 2021, from 11 recall events by 11 companies. 11 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. Avid Medical, Inc. · 1 event, 4 records, 4 Class I
  2. Covidien, LP · 1 event, 4 records
  3. DeRoyal Industries Inc · 1 event, 3 records, 3 Class I
  4. Philips North America Llc · 1 event, 2 records
  5. GE Healthcare, LLC · 1 event, 1 record
  6. Medtronic Vascular · 1 event, 1 record, 1 Class I
  7. Quidel Corporation · 1 event, 1 record, 1 Class I
  8. Skytron, Div. The KMW Group, Inc · 1 event, 1 record

FDA root cause

  1. Device Design · 5
  2. Material/Component Contamination · 4
  3. Environmental control · 4
  4. Nonconforming Material/Component · 3
  5. Software design · 1
  6. Process control · 1
  7. Component design/selection · 1
  8. Component change control · 1

Class I recalls (11)

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

Class II recalls (9)

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.