Guangdong Haiou Medical Apparatus Co., Ltd: Complaints received in which needle and needle holder have detached from the syringe after injection as well as needle not retracting into the syringe as per intended use, resulting in an increased risk of needle stick injury to the end user

Agency Publication Date: August 5, 2022

Affected Products

Product: HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box. Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-25G25

Lot Number: 20IB0 Exp. Date: 2025/09/04

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Number

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

Lot Number: 20JC2 Exp. Date: 2025/10/17; 21AA0 Exp Date: 2026/01/04

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90224

Status: Active

Manufacturer: Guangdong Haiou Medical Apparatus Co., Ltd

Manufactured In: China

Units Affected: 2 products (4,050,000 units; 7,218,000 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot Number: 20IB0 Exp. Date: 2025/09/04

Lot Numbers:

Number

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

Lot Number: 20JC2 Exp. Date: 2025/10/17; 21AA0 Exp Date: 2026/01/04

Lot Numbers:

Number