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Medical device recalls: October 2022

The FDA posted 153 medical device recall records in October 2022, from 51 recall events by 44 companies. 13 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. MEDLINE INDUSTRIES, LP - Northfield · 3 events, 7 records
  2. Baxter Healthcare Corporation · 2 events, 10 records, 5 Class I
  3. Synthes (USA) Products LLC · 2 events, 5 records
  4. Wright Medical Technology, Inc. · 2 events, 4 records
  5. Boston Scientific Corporation · 2 events, 3 records
  6. Siemens Healthcare Diagnostics, Inc. · 2 events, 3 records
  7. Hobbs Medical, Inc. · 1 event, 61 records
  8. Medicina Uk Ltd · 1 event, 8 records

FDA root cause

  1. Process control · 72
  2. Under Investigation by firm · 31
  3. Error in labeling · 11
  4. Device Design · 9
  5. Nonconforming Material/Component · 8
  6. Process design · 4
  7. Software design · 2
  8. Process change control · 2

Class I recalls (13)

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

Class II recalls (139)

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

Class III recalls (1)

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.