Medline Procedure Kits Recalled for Surgical Mask Bioburden Testing Failure
Medline has recalled 749 procedure kits containing surgical masks that failed to meet bioburden testing standards under EN 14683. The affected kits were distributed nationwide.
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 is a Class II FDA recall involving surgical masks that failed to meet bioburden sterility testing standards. The masks represent a risk-of-harm product due to potential sterility compromise. No illnesses or injuries have been reported, which prevents a higher classification.
Plain-English summary
Medline Industries is recalling approximately 749 procedure kits that were manufactured with Procedure Masks with SO SOFT Earloops and SOFT TOUCH II Surgical Masks. These masks did not meet the bioburden testing requirements of EN 14683, a standard that ensures masks meet sterility specifications.
The recalled products include two product lines: Port Access Kits (Reorder number CVI5130) and VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US (Reorder number STCVC01USGV). The kits were distributed nationwide throughout the United States.
Healthcare facilities and providers who have received these kits should discontinue use of the recalled masks immediately. Medline Industries should be contacted for replacement products. The failure to meet bioburden testing standards means the masks may not provide the intended level of sterility protection during medical procedures.
The recalled product
- Product
- Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-failure
- bioburden
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 (7)
- 1) CVI5130: UDI/DI 10653160372349 (each) 00653160372342 (case)
- Lot Numbers: 2024040490
- 2024073190
- 2024082790
- 2024101790
- 2) STCVC01USGV: UDI/DI 10653160376965 (each) 00653160376968 (case)
- Lot Numbers: 2024050990.
Distribution
Distributed nationwide across the United States.
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