Z-1506-2022Class II

HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box

Name: Z-1506-2022 HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box
Creator: Guangdong Haiou Medical Apparatus Co., Ltd
Published: 2022-06-10
License: https://open.fda.gov/license/

Guangdong Haiou Medical Apparatus Co., Ltd. / initiated 2022-06-10 / Open, Classified

FDA source

Guangdong Haiou Medical Apparatus Co., Ltd began a recall of HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box. Intended Use: Disposable sterile needle retractable... on 2022-06-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1506-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-10
Posted: 2022-08-05
Recalling firm: Guangdong Haiou Medical Apparatus Co., Ltd.
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
Product code: MEG Syringe, Antistick
Reason for recall: 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
FDA root cause: No Marketing Application
Action: Guangdong Haiou Medical., LTD (Haiou) contacted direct consignee by email on [10-Jun-2022] and Formal Recall Urgent Medical Device Recall letter through email and first-class letter. Letter states reason for recall, health risk and action to take: " Remove product from sale and cease distribution of product subject to this recall action. " Immediately review your inventory for the specific Product Description and Lot Number listed above and place into quarantine until further notice. " Notify us of any stock you have still under your direct control " Notify all customers to whom you have distributed this product of this recall. Use the template provided with this letter. " Complete the attached Customer Response Form and return to the Haiou contact noted on the form whether or not you have any of the impacted material so that Haiou may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement. " Forward any customer complaints for the use of this product to Haiou as per the contact information provided. Jiehong Luo QA Manager Phone:+ 86-663-2900999 Email: [email protected] Address: Nanyuan Industrial Zone, North Liusha, Puning City, Guangdong, China
Quantity in commerce: 4,050,000 units
Distribution: US Nationwide distribution in the state of CA.
Product codes and lots: Lot Number: 20IB0 Exp. Date: 2025/09/04

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1506-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1506-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-05
Z-1507-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-05

Product code MEG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)