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Medical device recalls: May 2020

The FDA posted 68 medical device recall records in May 2020, from 21 recall events by 19 companies. 7 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 Medical Solutions USA, Inc · 2 events, 5 records
  2. Beckman Coulter Inc. · 2 events, 3 records
  3. Howmedica Osteonics Corp. · 1 event, 16 records
  4. Access Scientific LLC · 1 event, 12 records
  5. Osteomed, LLC · 1 event, 12 records
  6. Applied Medical Resources Corp · 1 event, 3 records, 3 Class I
  7. Philips North America, LLC · 1 event, 3 records
  8. Argon Medical Devices, Inc · 1 event, 2 records, 2 Class I

FDA root cause

  1. Packaging · 28
  2. Vendor change control · 12
  3. Process control · 6
  4. Nonconforming Material/Component · 4
  5. Process design · 3
  6. Device Design · 3
  7. Component change control · 3
  8. Package design/selection · 2

Class I recalls (7)

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

Class II recalls (61)

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.