CLASS II Device recall · Reported 17 Nov 2021 · FDA Enforcement Report
Henry Schein Safety Blood Collection Needle 22Gx recalled
Zhejiang Kindly Medical Devices is recalling Henry Schein Safety Blood Collection Needle 22Gx 1, distributed nationwide in the US. The recall was initiated on 24 Aug 2021 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-0209-2022
- FDA event ID
- 88757
- Recalling firm
- Zhejiang Kindly Medical Devices, Wenzhou, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Aug 2021
- FDA classified
- 5 Nov 2021
- Reported
- 17 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 24 Aug 2021 | Recall initiated by company | |
| 5 Nov 2021 | Classified by FDA | +73 days |
| 17 Nov 2021 | 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
Potential for difficulty in safety mechanism activation.
Product as listed by the FDA
HENRY SCHEIN Safety Blood Collection Needle 22Gx 1 1/4 Inch, REF 570-2068, 100pcs/box 1000pcs/ctn 350*210*350mm
Where it was distributed
U.S. Nationwide distribution.
Questions about this recall
Why was it recalled?
Potential for difficulty in safety mechanism activation.
Which lots are affected?
Lot Numbers / Expiration Date: 20201030 / Exp. Date 2025.10.29, 20201210 / Exp. Date 2025.12.09.
Where was it sold?
U.S. Nationwide distribution.
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
5 other products · FDA event 88757This product is part of a recall event; the main page for the event is Henry Schein Safety Blood Collection Needle 21Gx recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Henry Schein Safety Blood Collection Needle 21Gx recalled | Zhejiang Kindly Medical Devices | Other | Nationwide | |
| CLASS II | McKesson Prevent HT Safety Winged Blood Collection Needle recalled | Zhejiang Kindly Medical Devices | Other | Nationwide | |
| CLASS II | McKesson Prevent HT Safety Winged Blood Collection Needle recalled | Zhejiang Kindly Medical Devices | Other | Nationwide | |
| CLASS II | McKesson Prevent HT Safety Blood Collection Needles recalled | Zhejiang Kindly Medical Devices | Other | Nationwide | |
| CLASS II | McKesson Prevent HT Safety Blood Collection Needles recalled | Zhejiang Kindly Medical Devices | Other | Nationwide |
More recalls from Zhejiang Kindly Medical Devices
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | McKesson Prevent HT Safety Blood Collection Needles recalled | Zhejiang Kindly Medical Devices | Other | Nationwide |
| Device | CLASS II | McKesson Prevent HT Safety Blood Collection Needles recalled | Zhejiang Kindly Medical Devices | Other | Nationwide |
| Device | CLASS II | McKesson Prevent HT Safety Winged Blood Collection Needle recalled | Zhejiang Kindly Medical Devices | Other | Nationwide |
| Device | CLASS II | McKesson Prevent HT Safety Winged Blood Collection Needle recalled | Zhejiang Kindly Medical Devices | Other | Nationwide |
| Device | CLASS II | Henry Schein Safety Blood Collection Needle 21Gx recalled | Zhejiang Kindly Medical Devices | Other | Nationwide |
Other Syringes & Needles recalls
All 1,060| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |