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Medical device recalls: September 2022

The FDA posted 117 medical device recall records in September 2022, from 39 recall events by 36 companies. 16 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. Philips Respironics, Inc. · 2 events, 11 records, 11 Class I
  2. Baxter Healthcare Corporation · 2 events, 2 records, 1 Class I
  3. Siemens Healthcare Diagnostics, Inc. · 2 events, 2 records
  4. Cook Incorporated · 1 event, 24 records
  5. Mckesson Medical-Surgical Inc. Corporate Office · 1 event, 23 records
  6. Carefusion · 1 event, 9 records
  7. Leica Microsystems, Inc. · 1 event, 4 records
  8. Datascope Corporation · 1 event, 3 records

FDA root cause

  1. Under Investigation by firm · 44
  2. Environmental control · 23
  3. Error in labeling · 14
  4. Process control · 13
  5. Device Design · 6
  6. Component change control · 4
  7. Vendor change control · 3
  8. Radiation Control for Health and Safety Act · 2

Class I recalls (16)

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

Class II recalls (76)

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

Class III recalls (25)

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.