CLASS II ONGOING Device recall · Reported 17 Aug 2022 · FDA Enforcement Report

Haiou Needle Retractable Safety Syringe with Needle-(0.6x25mm)./Box recalled

Guangdong Haiou Medical Apparatus is recalling Haiou Needle Retractable Safety Syringe with Needle-(0.6x25mm)./Box, distributed nationwide in the US. The recall was initiated on 10 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 20JC2 Exp. Date: 2025/10/17; 21AA0 Exp Date: 2026/01/04
Quantity recalled7,218,000 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1507-2022
FDA event ID
90224
Recalling firm
Guangdong Haiou Medical Apparatus, Puning
Classification
Class II
Status
Ongoing
Recall initiated
10 Jun 2022
FDA classified
5 Aug 2022
Reported
17 Aug 2022
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Other Reasons

Timeline

10 Jun 2022Recall initiated by company
5 Aug 2022Classified by FDA+56 days
17 Aug 2022Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the state of CA.

Nationwide California

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

US Nationwide distribution in the state of CA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 90224
ReportedClassRecallCompanyReasonWhere
CLASS IIHaiou Needle retractable safety syringe recalledGuangdong Haiou Medical ApparatusOtherNationwide

More recalls from Guangdong Haiou Medical Apparatus

All 2
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIHaiou Needle retractable safety syringe recalledGuangdong Haiou Medical ApparatusOtherNationwide

Other Syringes & Needles recalls

All 1,060