Lower risk Medical device recall · FDA · Published December 20, 2022

Ultracell Wick 80cc Bag Recall: Packaging May Contaminate Product

Beaver Visite: Ultracell Wick with 80cc Collection Bag (20/box) recalled due to packaging with open seals risking product contamination. Check catalog #40430 and lot numbers 21M3820/21L3403 for affected units.

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

🇺🇸 FDA recall #Z-1199-2023Medical device Beaver Visitec ›

Lower-risk recall

Device packaging may contain open seals, compromising product sterility.

Take action

Contact the company

Recalling firmBeaver Visitec International, Inc.500 Totten Pond Rd, 10 City Point · Waltham, MA 02451-1916

✎ GovInfoNow plain-language explainer

Beaver Visitec recalls Ultracell Wick collection bags because the packaging might have open seals, which could let bacteria get into the product. This could lead to infections if used improperly. Read more at govinfonow.com/recall/59086-ultracell-wick-80cc-bag-recall-packaging-may-contaminate-product.

Source Summary by GovInfoNow · govinfonow.com/recall/59086-ultracell-wick-80cc-bag-recall-packaging-may-contaminate-product · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1199-2023

Cite this page

“Ultracell Wick 80cc Bag Recall: Packaging May Contaminate Product.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59086-ultracell-wick-80cc-bag-recall-packaging-may-contaminate-product. Based on FDA recall #Z-1199-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1199-2023%22&limit=1).

Beaver Visitec International, Inc. voluntarily recalled Ultracell Wick with 80cc Collection Bag units due to packaging containing open seals that compromise sterility, according to the FDA on December 20, 2022.

How to tell if you have it

Brand: Beaver Visitec
Product: Ultracell Wick with 80cc Collection Bag, 20/box
Catalog #: 40430
Lot Numbers: 21M3820 and 21L3403
UDI/DI: 30886158012123

The hazard

The device packaging may contain open seals, which compromises product sterility.

Context

GovInfoNow's records show Beaver-Visitec International, Inc. has 15 other recalls on record since November 3, 2017. Recent brand recalls include the OME6000U Laser System Recall (December 5, 2025), CustomEyes Procedure Packs recall (July 26, 2024), and Xstar Safety Slit Knife Recall (May 10, 2024). Other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Microbial Contamination from Packaging Wrinkles (June 12, 2026), Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026), and Medline Medical Kits Recall: Open Seal Risk in BD ChloraPrep Swabsticks (December 24, 2025).

How to tell if you have this one

Check for the product name 'Ultracell Wick with 80cc Collection Bag, 20/box' with catalog number 40430 and lot numbers 21M3820 or 21L3403. The UDI/DI code 30886158012123 is also associated with this recall.

Brand
Beaver Visitec
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
Ongoing
Distribution
US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa

Recall number	Product, codes & lots
Z-1199-2023	Ultracell Wick with 80cc Collection Bag, 20/box; Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123
Z-1200-2023	CustomEyes kits; Catalog #BVI-58001086 and BVI-58001089, Lot Numbers 6051841, 6052299, 6051842, 6052300 UDI/DI: 50886158021990 and 50886158021969

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the catalog number (40430) and lot numbers (21M3820 or 21L3403) on the packaging.

Where it went and when

Where it was distributed

Distributed in 26 states and D.C., and outside the U.S.

FDA distribution: “US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Louisiana, Maryland, Minnesota, Montana, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 3 months after the firm started it.

Dec 20, 2022Firm started the recall
Mar 1, 2023FDA classified it Class II
Mar 8, 2023Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product safe to use?

The recall states the packaging may have open seals that could compromise sterility, so it is not safe to use as intended without checking the recall.

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Link to this recall

<a href="https://govinfonow.com/recall/59086-ultracell-wick-80cc-bag-recall-packaging-may-contaminate-product">Ultracell Wick 80cc Bag Recall: Packaging May Contaminate Product (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-1199-2023 (December 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1199-2023 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.