The Recall Desk
HighFDA (Devices)·Z-0849-2020·Announced 2020-02-05

Vitreq Recalls VitreQ 23G Injection Needles Due to Sterility Concerns

Vitreq Bv is recalling VitreQ 23G PFC Injection 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 is classified as FDA Class II and involves a risk of harm (compromised sterility) where specific injury reports are not detailed in the source text, fitting the High severity criteria for risk-of-harm products.

Plain-English summary

Vitreq Bv is voluntarily recalling VitreQ 23G PFC Injection Needles (Ref: MD23.D01, GTIN: 8719214221362). The recall is being conducted because microscopic tears in the sterile pouch may compromise the sterility of the product.

The recall covers all lots of the product and is distributed nationwide. The U.S. Food and Drug Administration has classified this as a Class II recall.

Healthcare providers and consumers should stop using the affected needles and contact the manufacturer for further instructions or a replacement.

The recalled product

Product
VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362
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

See all →

Same hazard · sterility compromise

See all →