Lower risk Medical device recall · FDA · Published September 14, 2020

Medline Vascular Surgery Kits Recalled: Non-sterile Kits Sold Without Sterilization

Medline recalls specific vascular surgery kits that were sold to facilities without sterilization capabilities, posing a risk of infection due to non-sterile use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0062-2021Medical device Medline ›

Lower-risk recall

Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilization capabilities.

Take action

Contact the company

Recalling firmMedline Industries Inc3 Lakes Dr · Northfield, IL 60093-2753

✎ GovInfoNow plain-language explainer

Medline is recalling certain vascular surgery kits that were sold to healthcare facilities without the ability to sterilize them. Using these kits without proper sterilization could lead to infections. Read more at govinfonow.com/recall/64288-medline-vascular-surgery-kits-recalled-non-sterile-kits-sold-without.

Source Summary by GovInfoNow · govinfonow.com/recall/64288-medline-vascular-surgery-kits-recalled-non-sterile-kits-sold-without · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0062-2021

Cite this page

“Medline Vascular Surgery Kits Recalled: Non-sterile Kits Sold Without Sterilization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64288-medline-vascular-surgery-kits-recalled-non-sterile-kits-sold-without. Based on FDA recall #Z-0062-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0062-2021%22&limit=1).

The FDA announced on 2020-09-14 that Medline Industries Inc is recalling Kit Model #650301018 because non-sterile kits intended for sterilization were sold to accounts lacking sterilization capabilities.

How to tell if you have it

Brand: Medline
Product: MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits
Model #: 650301018
Lot: 5554524, Exp 12/31/2022
Second lot with no lot recorded and no exp identified
Quantity: 80 kits
Distribution: US Nationwide including CA, CO, CT, OH, TX, and NY

The hazard

The recall involves non-sterile kits that were intended to be sterilized prior to use but were sold to accounts without sterilization capabilities.

Context

GovInfoNow's records show Medline Industries Inc has had 48 other recalls since 2015-09-25. Other recent recalls of similar products include Medline Chest Tube Kit Recalled: Non-sterile Tape in Sterile Component (2022-07-21), Medline Hand Sanitizer Foam Recall: Leaking Containers and Dispensing Issues (2021-11-08), and Medline Venous Access Kit Recall: Expired NaCl Bag Risk (2021-10-27). Additional similar recalls include Medline Convenience Kits Recall: Risk of Contaminated Sterile Products (2026-01-07), Medline Convenience Kits Recall: Sterile Saline Wound Wash May Not Meet Sterility Standards (2026-01-05), and Medline Convenience Kits: Risk of Contaminated Sterilization (2026-01-07).

How to tell if you have this one

Look for the kit model #650301018 with lot number 5554524 (expiring 12/31/2022) or a second lot with no lot or expiration date.

Brand
Medline
Category
Medical device

FDA recall event · 8 products

All 8 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 including in the states of CA, CO, CT, OH, TX, and NY.

Recall number	Product, codes & lots	Quantity
Z-0061-2021	Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).; Lot 5574586, Exp 01/31/2023	60 kits
Z-0062-2021	Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).; Lot 5554524, Exp 12/31/2022; second lot with no lot recorded and no exp identified	80 kits
Z-0063-2021	Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).; Lot 5551869, Exp 01/31/2022	20 kits
Z-0064-2021	Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).; Lot 5550988. Exp not identified but manufactured 11/22/2019; Second included lot with unidentified lot number and no identified exp	80 kits
Z-0065-2021	Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).; Lot is not recorded and expiration date is not identified	16 kits
Z-0066-2021	Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).; Lot 5551428, Exp 11/30/2022	32 kits
Z-0067-2021	Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).; Lot 5554476, Exp 11/30/2022	16 kits
Z-0068-2021	Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original equipment manufacturers (OEM).; Lot 5619215, Exp 06/30/2023	16 kits

Based on the official FDA remedy

What to do — step by step

Check Kit Details
Identify the kit model number and lot information to confirm if it matches the recalled items.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 6 states.

FDA distribution: “US Nationwide distribution including in the states of CA, CO, CT, OH, TX, and NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Colorado, Connecticut, New York, Ohio, Texas.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

Sep 14, 2020Firm started the recall
Oct 7, 2020FDA classified it Class II
Oct 14, 2020Published in FDA’s Enforcement Report
Apr 9, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Medline recalls

Link to this recall

<a href="https://govinfonow.com/recall/64288-medline-vascular-surgery-kits-recalled-non-sterile-kits-sold-without">Medline Vascular Surgery Kits Recalled: Non-sterile Kits Sold Without Sterilization (GovInfoNow)</a>

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-0062-2021 (September 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0062-2021 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.