Haiou Needle Retractable Safety Syringe recalls due to needle detachment risk
Approximately 7,218,000 Haiou Needle Retractable Safety Syringes are being recalled due to needle detachment and retracting mechanism failures that increase needlestick injury risk. The affected product was distributed in California.
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: FDA Class II recall involving product failure that creates a needlestick injury hazard. The source does not report any illnesses or injuries to date. Per the severity rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
The U.S. Food and Drug Administration has recalled 7,218,000 Haiou Needle Retractable Safety Syringes (Catalog Number NRSS1-23G25) manufactured by Guangdong Haiou Medical Apparatus Co., Ltd. These are 1ML, 23-gauge by 1-inch (0.6mm x 25mm) disposable sterile syringes packaged 200 units per box and intended for medical use.
The recall addresses reports of device failure in which the needle and needle holder detach from the syringe barrel after injection. Additionally, the needle mechanism may fail to retract into the syringe as designed. These failures eliminate the safety protection the product is intended to provide and increase the risk of needlestick injury to healthcare workers and other end users.
The affected products were distributed in California. Two lot numbers are identified: Lot 20JC2 (Expiration Date October 17, 2025) and Lot 21AA0 (Expiration Date January 4, 2026).
Users of these syringes should stop using them immediately and contact their medical supply vendor regarding replacement or return of the affected product.
The recalled product
- Product
- Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-23G25
- Manufacturer
- Guangdong Haiou Medical Apparatus Co., Ltd
- Hazard
- needle-stick
- needle-detachment
- retraction-failure
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 (2)
- Lot Number: 20JC2 Exp. Date: 2025/10/17
- 21AA0 Exp Date: 2026/01/04
Distribution
Distributed nationwide across the United States.
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