Vitreq Recalls VitreQ 23G Silicone Tipped Cannula Due to Sterility Concerns
Vitreq Bv is recalling VitreQ 23G Silicone Tipped Cannulas because microscopic tears in the sterile pouch may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product (compromised sterility) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Vitreq Bv is recalling VitreQ 23G Silicone Tipped Cannulas (GTIN: 8719214221508) due to a potential sterility issue. The recall is being conducted by the U.S. Food and Drug Administration (FDA) under recall number Z-0855-2020.
The recall is necessary because microscopic tears in the sterile pouch may compromise the sterility of the device. This defect could potentially affect the safety of the product for medical use.
The recall covers all lots of the product, which were distributed nationwide. Healthcare providers and facilities that have received this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the units.
The recalled product
- Product
- VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508
- Manufacturer
- Vitreq Bv
- Hazard
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 (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Vitreq Bv under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →Related recalls
Same manufacturer · Vitreq Bv
See all →- HighVitreq Recalls VitreQ 23G Cannulas Due to Potential Sterility Compromise
FDA (Devices) · 2020-02-05
- HighVitreq 25G Blunt and Brush Needles Recalled for Sterility Risk
FDA (Devices) · 2020-02-05
- HighVitreq Bv Recalls VitreQ 25G Blunt Needles Due to Sterility Concerns
FDA (Devices) · 2020-02-05
- HighVitreq Recalls VitreQ 20G VFI Cannulas Due to Sterility Concerns
FDA (Devices) · 2020-02-05
- HighVitreq Bv Recalls VitreQ 23G Pick Needles Due to Sterility Concerns
FDA (Devices) · 2020-02-05
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
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