Lower riskMedical device recall · FDA · Published March 10, 2021
Oscor AngioDynamics SafeSheath ULTRALITE 10F recall: Potential open seal on sterile
Oscor recalls AngioDynamics SafeSheath ULTRALITE 10:10F model VI10 due to potential open seal on sterile product. This could compromise sterility during medical procedures.
“Oscor AngioDynamics SafeSheath ULTRALITE 10F recall: Potential open seal on sterile.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63109-oscor-angiodynamics-safesheath-ultralite-10f-recall-potential-open-seal-on. Based on FDA recall #Z-1329-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1329-2021%22&limit=1).
The FDA announced on March 10, 2021, that Oscor Inc. is recalling AngioDynamics SafeSheath ULTRALITE 10F devices due to a potential open seal on the sterile product. The agency issued recall number Z-1329-2021 for the Class II voluntary recall.
How to tell if you have it
Brand: Oscor
Product: AngioDynamics SafeSheath ULTRALITE 10F
Model Number: VI10
Lot Number: DP-11759
GUDID: 25051684026298
The hazard
The recall addresses the potential for an open seal on the sterile product. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Oscor Inc. has three other recalls on record since September 26, 2018. Other recent recalls of similar products include Medline Sterile Resuture Pack Kits Recall (December 24, 2025), Medline PowerGlide Dressing Kits Recall (December 24, 2025), and Medline Medical Kits Recall (December 24, 2025).
How to tell if you have this one
Check for the model number VI10 on the device. The product was sold with lot number DP-11759 and is intended for medical use.
Brand
Oscor
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Seal
Inspect the device for any signs of an open seal. If the seal appears compromised, do not use the device.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of New York.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.4 years 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-1329-2021 (March 10, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1329-2021 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.