Ultracell Wick with Collection Bag Recalled for Compromised Packaging Sterility
Beaver Visitec International recalls Ultracell Wick with 80cc Collection Bag due to packaging with potentially open seals that may compromise product sterility. The recall affects 4,640 units distributed across the United States and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a potential sterility compromise due to open packaging seals. While no illnesses or injuries have been reported, sterility issues in medical devices present a risk of harm, meeting the criteria for a High severity score.
Plain-English summary
Beaver Visitec International, Inc. is recalling Ultracell Wick with 80cc Collection Bag, 20/box (Catalog #40430, Lot Numbers 21M3820 and 21L3403, UDI/DI: 30886158012123). A total of 4,640 units have been distributed.
The device packaging may contain open seals, which can compromise the product's sterility. Sterility is critical for medical devices to prevent infection and ensure patient safety.
The affected devices were distributed throughout the United States, including Alabama, California, Colorado, District of Columbia, Florida, Georgia, Illinois, Louisiana, Maryland, Minnesota, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Vermont, Washington, and Wisconsin. Additionally, units were distributed internationally to Canada, Japan, and South Africa. Those who have received units from the recalled lot numbers (21M3820 and 21L3403) should not use them due to the sterility concern.
The recalled product
- Product
- Ultracell Wick with 80cc Collection Bag, 20/box
- Manufacturer
- Beaver Visitec International, Inc.
- Category
- Medical Device
- Hazard
- compromised-sterility
- open-seal
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog #40430
- Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123
Distribution
Distributed in 27 states:
- 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
- WI
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