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Medical device recalls: June 2022

The FDA posted 21 medical device recall records in June 2022, from 14 recall events by 10 companies. 4 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. GE Healthcare, LLC · 3 events, 8 records, 2 Class I
  2. Getinge Usa Sales Inc · 2 events, 3 records, 2 Class I
  3. Siemens Medical Solutions USA, Inc · 2 events, 2 records
  4. Medtronic Xomed, Inc. · 1 event, 2 records
  5. ARROW INTERNATIONAL Inc. · 1 event, 1 record
  6. Canon Medical System, USA, INC. · 1 event, 1 record
  7. Changzhou Biomet Medical Devices CO., Ltd. · 1 event, 1 record
  8. Howmedica Osteonics Corp. · 1 event, 1 record

FDA root cause

  1. Software design · 7
  2. Under Investigation by firm · 3
  3. Software Design Change · 3
  4. Process control · 3
  5. Process change control · 2
  6. Component design/selection · 2
  7. Error in labeling · 1

Class I recalls (4)

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

Class II recalls (17)

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.