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Medical device recalls: October 2020

The FDA posted 21 medical device recall records in October 2020, from 10 recall events by 9 companies. 12 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. Siemens Healthcare Diagnostics, Inc. · 2 events, 3 records
  2. Baxter Healthcare Corporation · 1 event, 4 records, 4 Class I
  3. Vascular Solutions, Inc. · 1 event, 4 records, 4 Class I
  4. Medtronic Vascular · 1 event, 3 records, 3 Class I
  5. Pentax of America Inc · 1 event, 2 records
  6. RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) · 1 event, 2 records
  7. Biomet, Inc. · 1 event, 1 record
  8. Encore Medical, LP · 1 event, 1 record

FDA root cause

  1. Device Design · 7
  2. Process control · 5
  3. Labeling design · 4
  4. Under Investigation by firm · 2
  5. Software design · 2
  6. Process change control · 1

Class I recalls (12)

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.