Radiometer Arterial Blood Sampler May Have Contaminated Sterility Risk
Radiometer recalls arterial blood samplers due to potential sterility issues. All units sold may be affected. Consumers should contact Radiometer for details.
Lower-risk recall
Arterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product.
Contact the company
What happened, in plain English
Radiometer is recalling arterial blood samplers that may not be sterile throughout their shelf life. This could lead to infections if used improperly. Read more at govinfonow.com/recall/60829-radiometer-arterial-blood-sampler-may-have-contaminated-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/60829-radiometer-arterial-blood-sampler-may-have-contaminated-sterility-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1115-2022
Cite this page
“Radiometer Arterial Blood Sampler May Have Contaminated Sterility Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60829-radiometer-arterial-blood-sampler-may-have-contaminated-sterility-risk. Based on FDA recall #Z-1115-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1115-2022%22&limit=1).
Why it’s dangerous
The blood samplers may not maintain sterility over time, increasing infection risk during medical procedures. This is a potential issue for patients undergoing blood tests.
Who’s affected
Healthcare professionals and patients using arterial blood samplers for medical testing. Those with specific medical conditions requiring frequent blood tests are at higher risk.
How to tell if you have this one
Check for the model number REF:956-552, PIC050 on the product. The product is sold as an arterial blood sampler with 2 mL capacity and 80 IU heparin.
- Brand
Radiometer- Category
Medical device
What to do — step by step
Contact Radiometer
Reach out to Radiometer Medical ApS for specific instructions on handling the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 27 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DC, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NM, NY, OH, OK, OR, PA, TN, TX, WA, WI and the countries of Canada, Italy, Norway, Austria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1115-2022 (April 8, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1115-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.