Lower riskMedical device recall · FDA · Published March 26, 2021
Radiometer PICO70 Arterial Blood Sampler: Remote Risk of Bacterial Infection
Radiometer recalls PICO70 arterial blood samplers due to a remote risk of bacterial bloodstream infection, especially for immunosuppressed patients. The issue involves potential breaches in the sterile barrier system.
Radiometer has become aware of an issue with PICO70 Arterial Blood Sampler. The issue relates to the sterile barrier system for the product. During internal stress testing on PICO70 Arterial Blood Samplers a breach in the sterile barrier system was observed in one sample. Risk for the patient: The described error is considered to have a remote possibility of resulting in bacterial bloodstream infection. The bloodstream infection may be asymptomatic but may also progress to sepsis or life-threatening septic shock. Immunosuppressed patients are at particular risk. Due to issues (breaches) with the sterile barrier system for the Arterial Blood Sampler.
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Contact the company
📍Recalling firmRadiometer Medical ApSAkandevej 21 · Bronshoj, Denmark
“Radiometer PICO70 Arterial Blood Sampler: Remote Risk of Bacterial Infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62905-radiometer-pico70-arterial-blood-sampler-remote-risk-of-bacterial-infection. Based on FDA recall #Z-1683-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1683-2021%22&limit=1).
The FDA announced on March 26, 2021, that Radiometer Medical ApS is recalling PICO70 Arterial Blood Samplers due to a breach in the sterile barrier system. This defect poses a remote risk of bacterial bloodstream infection, which may progress to sepsis or life-threatening septic shock.
How to tell if you have it
Brand: Radiometer
Product: PIC070 Arterial Blood Sampler PICO70
Model Numbers: 956-518, 956-519, 956-522, 956-525, 956-529, 956-533, 956-534, 956-547
Radiometer observed a breach in the sterile barrier system during internal stress testing. The FDA states this error has a remote possibility of resulting in bacterial bloodstream infection. The infection may be asymptomatic or progress to sepsis or life-threatening septic shock, with immunosuppressed patients at particular risk.
Context
GovInfoNow's records show Radiometer Medical ApS has issued 16 other recalls since February 27, 2018. Recent brand recalls include the March 21, 2025, recall of ABL90 FLEX Analyzers for freezing during tests and the May 31, 2024, recall of ABL800 FLEX Analyzers for calibration solution pH issues. Other recent recalls of similar products include the December 19, 2025, ICU Medical Pulsator Arterial Blood Sampling Kit Recall and the December 11, 2025, Instrumentation Laboratory Coagulation Test Kits recall.
How to tell if you have this one
Check for model numbers 956-518, 956-519, 956-522, 956-525, 956-529, 956-533, 956-534, or 956-547 on the sampler. These models are part of the PICO70 arterial blood sampler line.
Brand
Radiometer
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Model
Look for model numbers 956-518, 956-519, 956-522, 956-525, 956-529, 956-533, 956-534, or 956-547 on the sampler.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - U.S. Nationwide distribution in the states of CA, CO, FL, IL, LA, MA, MI, MO, MT, NJ, NY, OK, PA, TX, WA, and WI. The countries of Australia, New Zealand, Canada, Algeria, Bahrain, Belarus, Bosnia and Herzegovina,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Illinois, Louisiana, Massachusetts, Michigan, Missouri, Montana, New Jersey, New York, Oklahoma, Pennsylvania, Texas, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1683-2021 (March 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1683-2021 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.