BD Ultra Touch Blood Collection Sets: Sterility Risk
Becton Dickinson recalls Ultra Touch Blood Collection Sets due to potential failure to meet sterility standards. Affected units may not be sterile, risking infection during blood draws.
Lower-risk recall
Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.
Contact the company
What happened, in plain English
Becton Dickinson is recalling Ultra Touch Blood Collection Sets because they might not be sterile as claimed. This could lead to infections if used for blood draws without proper sterility. Read more at govinfonow.com/recall/71676-bd-ultra-touch-blood-collection-sets-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/71676-bd-ultra-touch-blood-collection-sets-sterility-risk · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1533-2018
Cite this page
“BD Ultra Touch Blood Collection Sets: Sterility Risk.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71676-bd-ultra-touch-blood-collection-sets-sterility-risk. Based on FDA recall #Z-1533-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1533-2018%22&limit=1).
Why it’s dangerous
The sets may not meet the required sterility level (SAL 10-6), meaning they might not be sterile enough for medical use. This could allow bacteria to contaminate blood samples during collection, increasing infection risk.
Who’s affected
Healthcare professionals and lab staff who use these blood collection sets are most at risk. Patients using the sets for blood draws could also face infection risks.
How to tell if you have this one
Look for the product name 'BD Ultra TouchTM Push Button Blood Collection Set' with catalog numbers 367364 or 7348980. The sets are 0.6 x 19 mm x 305 mm and 23G size.
- Brand
Becton Dickinson- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania
| Recall number | Product, codes & lots |
|---|---|
| Z-1531-2018 | BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342); 7354908 8005794 8005795 8005796 8010728 8010732 8012784 8012844 8012848 8018509 8019702 |
| Z-1532-2018 | BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344; 7346627 7348974 7348975 7354740 7354743 7354745 7354764 8005556 8005557 8005814 8010735 8012910 8015923 8015925 |
| Z-1533-2018 | BD Vacutainer¿ Ultra TouchTM Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12. Catalog no 367364; 7348980 |
What to do — step by step
Check Product Details
Verify the catalog number on the product label to confirm if it's affected (367364 or 7348980).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.1 years 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-1533-2018 (March 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1533-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 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.