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Medical device recalls: July 2022

The FDA posted 35 medical device recall records in July 2022, from 17 recall events by 16 companies. 15 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 · 2 events, 2 records, 1 Class I
  2. Covidien Llc · 1 event, 9 records, 9 Class I
  3. Philips Medical Systems DMC GmbH · 1 event, 5 records
  4. American Contract Systems, Inc. · 1 event, 2 records, 2 Class I
  5. Arcoma AB · 1 event, 2 records
  6. Fresenius Medical Care Holdings, Inc. · 1 event, 2 records
  7. LumiraDx · 1 event, 2 records
  8. ROi CPS LLC · 1 event, 2 records

FDA root cause

  1. Process control · 14
  2. Under Investigation by firm · 7
  3. Radiation Control for Health and Safety Act · 5
  4. Device Design · 4
  5. Process change control · 3
  6. Software design · 2

Class I recalls (15)

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

Class II recalls (19)

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.