FDA Medical Device Recalls (openFDA)
Guangdong Haiou Medical Apparatus Co., Ltd: 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
- Recall number
- Z-1506-2022
- 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
- Status
- Open, Classified
- Initiated
- 2022-06-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- 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: qc@haiou.net.cn Address: Nanyuan Industrial Zone, North Liusha, Puning City, Guangdong, China
- Quantity
- 4,050,000 units
- Distribution
- US Nationwide distribution in the state of CA.
- Lot, serial or model codes
- Lot Number: 20IB0 Exp. Date: 2025/09/04
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MEG
- Firm FEI
- 3010596027
- Firm city
- Puning
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28