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
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
- Device type
- Syringes & Needles
Timeline
| 10 Jun 2022 | Recall initiated by company | |
| 5 Aug 2022 | Classified by FDA | +56 days |
| 17 Aug 2022 | Published 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.
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Haiou Needle retractable safety syringe recalled | Guangdong Haiou Medical Apparatus | Other | Nationwide |
More recalls from Guangdong Haiou Medical Apparatus
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Haiou Needle retractable safety syringe recalled | Guangdong Haiou Medical Apparatus | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS I | BD Needle Kit for Powered Driver recalled by Bard Access Systems | Bard Access Systems | Other | 32 states |
| Device | CLASS II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit recalled | Galt Medical | Other | Nationwide |
| Device | CLASS II | Geneva Brachytherapy Applicator recalled by Elekta | Elekta | Other | Nationwide |
| Device | CLASS II | Brachytherapy Applicator Advanced Gynecological Applicator recalled | Elekta | Other | Nationwide |
| Device | CLASS II | Medline 111 Gravity Set W/3 Needle Free Y-Sites recalled | BD Switzerland Sarl | Other | IL |