Hologic Affirm Lateral Arm Upright Biopsy Accessory Recall: Needle Alignment Risk
Hologic recalls Affirm Lateral Arm Upr: A component issue may affect needle alignment during breast biopsies. No injuries reported. Check product number ASY-09880 for affected units.
Lower-risk recall
The firm is implementing a product correction involving its Affirm¿ Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the aspiration of the intended tissue. This impact is case-dependent and detectable when imagining is used to confirm needle position and/or tissue acquisition during and after a procedure. There are no known instances of illness or injury.
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What happened, in plain English
Hologic is recalling its Affirm Lateral Arm Upright Biopsy Accessory (product number ASY-09880) because a component issue could cause needle misalignment during breast biopsies. This might lead to improper tissue sampling if not detected with imaging. No injuries have been reported. Read more at govinfonow.com/recall/73457-hologic-affirm-lateral-arm-upright-biopsy-accessory-recall-needle-alignment.
Source Summary by GovInfoNow · govinfonow.com/recall/73457-hologic-affirm-lateral-arm-upright-biopsy-accessory-recall-needle-alignment · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0351-2018
Cite this page
“Hologic Affirm Lateral Arm Upright Biopsy Accessory Recall: Needle Alignment Risk.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73457-hologic-affirm-lateral-arm-upright-biopsy-accessory-recall-needle-alignment. Based on FDA recall #Z-0351-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0351-2018%22&limit=1).
Why it’s dangerous
A component (Left-hand Guide or Blue Needle Guide) may cause needle misalignment during breast biopsies. This could lead to improper tissue sampling if not detected with imaging. The risk is case-dependent and not always noticeable.
Who’s affected
Patients undergoing breast biopsies using this accessory are most at risk. The product is used by medical professionals for left-approach lateral biopsies.
How to tell if you have this one
Check for product number ASY-09880 on the accessory. Serial numbers range from LAT1200100 to LAT1200165. This product was sold by Hologic.
- Brand
Hologic- Category
Medical device
What to do — step by step
Check Product Number
Look for product number ASY-09880 on the accessory.
How this recall unfolded
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0351-2018 (July 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0351-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.