The Recall Desk
HighFDA (Devices)·Z-0846-2020·Announced 2020-02-05

Vitreq 23G Needles Recalled for Potential Sterility Compromise

Vitreq Bv is recalling VitreQ 23G needles because microscopic tears in the sterile pouch may compromise sterility.

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: 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 23G BF Blunt Needles and VitreQ 23G BF Brush Needles. The recall is due to microscopic tears in the sterile pouch, which may compromise the sterility of the medical devices.

The recall covers all lots of the affected products, which were distributed nationwide. The specific GTIN numbers for the recalled items are 8719214221126 for the Blunt Needles and 8719214221140 for the Brush Needles.

Consumers and healthcare providers should stop using these products and contact the recalling firm for further instructions.

The recalled product

Product
(1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23.D52 GTIN#: 8719214221140
Manufacturer
Vitreq Bv
Category
Medical Device — Surgical Instruments
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

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Same hazard · sterility compromise

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