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Medical device recalls: December 2022

The FDA posted 444 medical device recall records in December 2022, from 68 recall events by 60 companies. 47 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 Medical Systems, LLC · 3 events, 15 records
  2. Medical Action Industries, Inc. 306 · 3 events, 3 records
  3. ARROW INTERNATIONAL Inc. · 2 events, 33 records, 33 Class I
  4. Baxter Healthcare Corporation · 2 events, 5 records
  5. Integrity Implants Inc. · 2 events, 4 records
  6. Siemens Healthcare Diagnostics, Inc. · 2 events, 4 records
  7. DeRoyal Industries Inc · 1 event, 156 records
  8. Stradis Medical, LLC dba Stradis Healthcare · 1 event, 78 records

FDA root cause

  1. Nonconforming Material/Component · 163
  2. Packaging process control · 80
  3. Under Investigation by firm · 78
  4. Pending · 31
  5. Device Design · 27
  6. Process control · 24
  7. Other · 9
  8. No Marketing Application · 6

Class I recalls (47)

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

Class II recalls (392)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Class III recalls (5)

Using the device is not likely to cause health problems, but it violates FDA rules.

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.