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Medical device recalls: May 2023

The FDA posted 211 medical device recall records in May 2023, from 71 recall events by 62 companies. 45 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. Ortho-Clinical Diagnostics, Inc. · 3 events, 5 records
  2. Maquet Medical Systems USA · 2 events, 18 records
  3. Philips North America · 2 events, 5 records
  4. Siemens Healthcare Diagnostics, Inc. · 2 events, 4 records
  5. Siemens Medical Solutions USA, Inc · 2 events, 4 records
  6. Olympus Corporation of the Americas · 2 events, 3 records
  7. Philips North America Llc · 2 events, 3 records
  8. Teleflex LLC · 2 events, 2 records

FDA root cause

  1. Under Investigation by firm · 55
  2. Labeling design · 49
  3. Process control · 27
  4. Vendor change control · 14
  5. Pending · 10
  6. Software design · 8
  7. Radiation Control for Health and Safety Act · 8
  8. Device Design · 8

Class I recalls (45)

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

Class II recalls (164)

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

Class III recalls (2)

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.