Vitreq Recalls VitreQ 25G Injection Needles Due to Sterility Concerns
Vitreq Bv is recalling VitreQ 25G PFC Injection Needles 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 (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Vitreq Bv is recalling VitreQ 25G PFC Injection Needles (Reference: MD25.D01, GTIN: 8719214221386). The recall was initiated because microscopic tears in the sterile pouch may compromise the sterility of the product.
The recall covers all lots of the affected product. The distribution pattern is listed as nationwide.
Consumers and healthcare providers should stop using the recalled needles and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386
- 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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