Angiodynamics recalls specific batch of Safe Sheath Ultralite vascular introducers due to potential sterility compromise. Affected units have Catalogue # VI10 and Lot # DP-11759. Contact for remedy.
AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified below is affected by this recall action. The Product Description, Product Number, Ref./Catalog Number and Batch/Lot number is provided below. No other products are affected by this recall.
Take action
Contact the company
📍Recalling firmAngiodynamics Inc. (Navilyst Medical Inc.)10 Glens Falls Tech Park · Glens Falls, NY 12801-3864
“Angiodynamics Safe Sheath Ultralite Recall: Potential Sterility Compromise.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63242-angiodynamics-safe-sheath-ultralite-recall-potential-sterility-compromise. Based on FDA recall #Z-1467-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1467-2021%22&limit=1).
The FDA announced on Feb. 22, 2021, that Angiodynamics Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers due to potential compromised sterility. The recall affects the AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer with Catalogue # VI10.
The recalled devices may have potential for compromised sterility of the device. The recall is limited to the specific product and lot identified in the record; no other products are affected.
Context
GovInfoNow's records show Angiodynamics Inc. (Navilyst Medical Inc.) has had 8 other recalls since Oct. 17, 2017. Previous issues included a Starburst Talon Electrosurgical Device recall on Oct. 2, 2019, for incorrect labeling and an Angiodynamics BIOFLO 8F Device recall on Sept. 18, 2019, due to connector issues. Other recent recalls of similar products include Arrow Pacing PSI Kit Recall (April 21, 2026), Medline ARTERIAL LINE INSERTION KIT Recall (June 12, 2026), and Medical Action Industries Epidural Kits Recall (July 23, 2026).
How to tell if you have this one
Check for Catalogue # VI10 and Lot # DP-11759 on the product label. Only this specific batch is affected by the recall.
Brand
Angiodynamics
Category
Medical device
FDA recall event · 2 products
All 2 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 distribution in the states of AR, CA, CO, FL, HI, IL, IN, KS, MI, MO, NC, ND, NM, NY, OH, OR, PA, SC, TN, TX, VA, WA.
Recall number
Product, codes & lots
Quantity
Z-1466-2021
Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Product Usage: indicated for any patient requiring repeated access of the vascular system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood and power injection of contrast media for imaging.; UPN: H787CT96STSDVI1, Lot #: 5616651, 5647359, 5654135 UPN: H787CT96STSAVI1, Lot #: 5654129
267 kits
Z-1467-2021
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.; UPN: VI10, Lot #: DP-11759
337 units, (14 boxes of 5, 267 units each kit)
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for Catalogue # VI10 and Lot # DP-11759 on the device label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 22 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AR, CA, CO, FL, HI, IL, IN, KS, MI, MO, NC, ND, NM, NY, OH, OR, PA, SC, TN, TX, VA, WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arkansas, California, Colorado, Florida, Hawaii, Illinois, Indiana, Kansas, Michigan, Missouri, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 17 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-1467-2021 (February 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1467-2021 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.