Stop using nowMedical device recall · FDA · Published June 16, 2021
Cardinal Health Argyle UVC Insertion Tray Safety Recall: Risk of Delayed Treatment
Cardinal Health recalls Argyle UVC Insertion Tray with Safety Scalpel N11 due to risk of delayed treatment causing death in neonatal care. All units sold are affected.
The current Argyle UVC Insertion Tray does not include a specific IFU to operate the Safety Scalpel N11. The Safety Scalpel N11 features a permanent locking feature that will not allow the clinician to unlock the scalpel once the safety shield is closed and pushed forward into a locked position may result in a delay treatment/therapy, which could ultimately result in death.
Take action
Contact the company
📍Recalling firmCardinal Health 200, LLC15 Hampshire St Bldg 5 · Mansfield, MA 02048-1113
“Cardinal Health Argyle UVC Insertion Tray Safety Recall: Risk of Delayed Treatment.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62334-cardinal-health-argyle-uvc-insertion-tray-safety-recall-risk-of. Based on FDA recall #Z-2244-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2244-2021%22&limit=1).
Cardinal Health 200, LLC recalled Argyle UVC Insertion Trays containing Safety Scalpel N11 due to a hazard that could result in death. The FDA announced the Class I recall on June 16, 2021.
The FDA said the trays lack specific instructions for use for the Safety Scalpel N11. This scalpel has a permanent locking feature that prevents unlocking once the safety shield is closed, potentially delaying treatment and resulting in death.
Context
GovInfoNow's records show Cardinal Health 200, LLC has 59 other recalls on record since June 27, 2017. Other recent recalls of similar products include Presource Packs with Microstream Components Risk of Delayed Treatment (Aug. 19, 2026), Presource Gyn Laparoscopy Kits May Leak Fluids During Use - Recall (Aug. 18, 2026), and Cardinal Health 200, LLC recalls Presource Convenience Kits (Aug. 10, 2026). Other recent recalls of similar products include Arrow PICC Access Tray Recall: Risk of Serious Injuries from Contaminated Medication (April 21, 2026), Arrow Access Tray Recall: Risk of Serious Injury from Contaminated Medication (April 21, 2026), and Medline PICC Tray DYNJ41648A Recall: Rescinded Regulatory Clearances (Feb. 25, 2026).
How to tell if you have this one
Check for the Argyle UVC Insertion Tray with Safety Scalpel N11 (vendor part number 73-1811). All units sold are affected, including those with product code 43201.
Brand
Cardinal Health
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the Argyle UVC Insertion Tray with Safety Scalpel N11 as it poses a risk of delayed treatment that could cause death.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class I
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-2244-2021 (June 16, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2244-2021 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.