Hologic, Inc 2026-05-20 Health serious FDA
Health · FDA · Recall #FDA-Z-2167-2026
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC,… Recall
Issued May 20, 2026 · Hologic, Inc
In May 2026, Hologic, Inc recalled the SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Complaints have been received of systems developing loose, missing, or broken internal bolts over time.
What you should do
- 1 Stop using SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Hologic, Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Hologic, Inc
- Category
- Health
- Recall date
- May 20, 2026
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-2167-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Hologic, Inc has 4 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 356th Health recall we've logged in 2026.