Skip to content

Medical device recalls: August 2020

The FDA posted 88 medical device recall records in August 2020, from 19 recall events by 14 companies. 13 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. CareFusion 303, Inc. · 4 events, 16 records, 11 Class I
  2. GE Healthcare, LLC · 2 events, 2 records
  3. Siemens Medical Solutions USA, Inc · 2 events, 2 records
  4. Globus Medical, Inc. · 1 event, 22 records
  5. Datascope Corporation · 1 event, 17 records
  6. Cardinal Health 200, LLC · 1 event, 8 records
  7. Flower Orthopedics Corporation · 1 event, 6 records
  8. HF Acquisition Co., LLC · 1 event, 4 records

FDA root cause

  1. Nonconforming Material/Component · 25
  2. Process change control · 21
  3. Device Design · 17
  4. Under Investigation by firm · 10
  5. Mixed-up of materials/components · 6
  6. Unknown/Undetermined by firm · 3
  7. Software design · 2
  8. Software Design Change · 1

Class I recalls (13)

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

Class II recalls (75)

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.