HAIOU Retractable Safety Syringes Recalled for Needle Detachment Risk
HAIOU retractable safety syringes are recalled due to reports of needle detachment from the syringe after injection and failure to retract, increasing needle stick injury risk. Approximately 4.05 million units are affected.
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 medical device recall without reported illnesses or injuries. The hazard—needle detachment and retraction failure creating needle stick injury risk—is a risk-of-harm scenario with no reported injuries, meeting the rubric criterion for High severity.
Plain-English summary
HAIOU retractable safety syringes (1ml with 25G x 1-inch needle, Catalog Number NRSS1-25G25) are being recalled due to reports of needle and needle holder detachment from the syringe after injection and failure of the needle to retract into the syringe as designed.
The product was manufactured by Guangdong Haiou Medical Apparatus Co., Ltd. Approximately 4.05 million units are affected, with Lot Number 20IB0 and expiration date of September 4, 2025.
These device malfunctions—needle detachment and retraction failure—create an increased risk of needle stick injury to users. The syringes are designed as disposable, sterile, needle retractable safety devices.
The recalled product
- 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
- Manufacturer
- Guangdong Haiou Medical Apparatus Co., Ltd
- Category
- Medical Device — Syringe
- Hazard
- needle-stick-injury
- 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 (1)
- Lot Number: 20IB0 Exp. Date: 2025/09/04
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- HighSurgify Halo surgical drill recalled for potential burr breakage
FDA (Devices) · 2026-07-01