Safety Blood Collection Needle Recalled for Safety Mechanism Activation Issues
Zhejiang Kindly Medical Devices is recalling Henry Schein Safety Blood Collection Needles due to potential difficulty activating the safety mechanism. Affected lot numbers distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II medical device recall with a potential safety mechanism defect but no reported injuries or illnesses. The product presents a risk of harm (needle stick injuries from failed safety mechanism) without yet-reported adverse events, meeting the criteria for High severity.
Plain-English summary
Zhejiang Kindly Medical Devices Co., Ltd. is recalling Henry Schein Safety Blood Collection Needles (21 gauge, 1 1/4 inch, model REF 570-2067). The recalled product includes needles with lot numbers 20201030 (expiration date 2025-10-29) and 20201210 (expiration date 2025-12-09), distributed nationwide in the United States.
The needles are being recalled due to potential difficulty in activating the safety mechanism. This defect could affect the product's ability to protect healthcare workers from needle stick injuries.
Healthcare facilities and professionals using these needles should immediately stop using the affected lot numbers and contact their supplier for instructions on return or replacement.
The recalled product
- Product
- HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
- Manufacturer
- Zhejiang Kindly Medical Devices Co., Ltd.
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 (2)
- Lot Numbers / Expiration Date: 20201030 / Exp. Date 2025.10.29
- 20201210 / Exp. Date 2025.12.09.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Zhejiang Kindly Medical Devices Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Zhejiang Kindly Medical Devices Co., Ltd.
See all →- HighMcKesson PREVENT HT Winged Blood Collection Needles Recall for Safety Mechanism Difficulty
FDA (Devices) · 2021-11-17
- HighSafety Blood Collection Needles Recalled Due to Safety Mechanism Activation Difficulty
FDA (Devices) · 2021-11-17
- HighMcKesson PREVENT HT Blood Collection Needle Safety Mechanism Activation Issue
FDA (Devices) · 2021-11-17
- HighMcKesson Safety Blood Collection Needles Recalled Over Safety Mechanism Activation Risk
FDA (Devices) · 2021-11-17
- HighMcKesson Safety Blood Collection Needles Recalled for Safety Mechanism Defect
FDA (Devices) · 2021-11-17
Same hazard · device malfunction
See all →- SevereMedtronic MiniMed Flex Insulin Pumps Recalled for Failed Verification Tests
FDA (Devices) · 2026-10-14
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect
FDA (Devices) · 2026-09-23
- HighDatex-Ohmeda Et Control Software Recalled for Anesthetic Delivery Interruption
FDA (Devices) · 2026-09-23
Similar recalls
- HighCardinal Health Recalls Magellan Hypodermic Safety Needles Due to Locking Failure
FDA (Devices) · 2021-03-24
- HighHaiou Needle Retractable Safety Syringe recalls due to needle detachment risk
FDA (Devices) · 2022-08-17
- HighCustom Healthcare Systems Recalls 250 LP Needle Kits Due to Sterility Compromise
FDA (Devices) · 2018-10-31
- HighCardinal Health Recalls Magellan Syringes Due to Safety Shield Defect
FDA (Devices) · 2021-03-24
- HighGlobal Healthcare Recalls VacuFlow Safe Blood Collection Sets
FDA (Devices) · 2016-09-28
- HighHAIOU Retractable Safety Syringes Recalled for Needle Detachment Risk
FDA (Devices) · 2022-08-17