Syringe, Antistick
General Hospital · 21 CFR 880.5860
Recent MDR events
2,941 adverse event reports on file
- SYRINGE WITH SAFETY HYPODERMIC NEEDLEJul 21, 2026MalfunctionTerumo Philippines Corporation3003902955-2026-00068
- VANISHPOINT II SYRINGEJul 1, 2026MalfunctionRetractable Technologies, Inc.MW5190182
- SURGUARD2 SAFETY HYPODERMIC NEEDLEJun 30, 2026MalfunctionTerumo Philippines Corporation3003902955-2026-00062
- SURGUARD2 SAFETY HYPODERMIC NEEDLEJun 23, 2026MalfunctionTerumo Philippines Corporation3003902955-2026-00059
- SURGUARD2 SAFETY HYPODERMIC NEEDLEJun 23, 2026MalfunctionTerumo Philippines Corporation3003902955-2026-00060
- SURGUARD2 SAFETY HYPODERMIC NEEDLEJun 19, 2026MalfunctionTerumo Philippines Corporation3003902955-2026-00058
- INTEGRA PrecisionGlideJun 18, 2026InjuryBecton Dickinson Medical Systems1213809-2026-00314
- BD SAFETYGLIDEJun 10, 2026MalfunctionEmbecta Medical I Llc2243072-2026-00433
- SYRINGE WITH SAFETY HYPODERMIC NEEDLE (MCKESSON PRIVATE LABEL)Jun 9, 2026MalfunctionTerumo Philippines Corporation3003902955-2026-00050
- SYRINGE WITH SAFETY HYPODERMIC NEEDLE (MCKESSON PRIVATE LABEL)Jun 9, 2026MalfunctionTerumo Philippines Corporation3003902955-2026-00052
Event type breakdown
Recalls
17 recall events for this product code
- Cardinal Health 200, LLCOpen, ClassifiedNov 8, 2024
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
Z-0310-2025 · View FDA record ↗ - Smiths Medical ASD Inc.TerminatedJun 10, 2021
JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE:
Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.
Z-1798-2021 · View FDA record ↗ - Terumo Medical CorpTerminatedDec 24, 2015
Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).
Z-0551-2016 · View FDA record ↗ - Smiths Medical ASD, Inc.TerminatedJan 8, 2014
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in
Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
Z-0642-2014 · View FDA record ↗ - Smiths Medical ASD, Inc.TerminatedJan 8, 2014
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in
Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
Z-0643-2014 · View FDA record ↗ - Smiths Medical ASD, Inc.TerminatedJan 8, 2014
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in
Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
Z-0644-2014 · View FDA record ↗ - Smiths Medical ASD, Inc.TerminatedJan 8, 2014
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in
Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
Z-0645-2014 · View FDA record ↗ - Smiths Medical ASD, Inc.TerminatedJan 8, 2014
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand)
Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin Syringes
Z-0646-2014 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedJun 21, 2013
BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.
There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.
Z-1577-2013 · View FDA record ↗ - Inviro Medical Devices, IncTerminatedJun 11, 2010
InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical Devices, Inc., Duluth, GA 30096 USA.
Syringe Defects. Group 1 syringes: The plunger pull out force was below specification. Group 2 syringes: The needle length is out of specification.
Z-1800-2010 · View FDA record ↗
Registered firms
283 firms currently registered for this product code
Gemtier Medical (shanghai) Inc.
Shanghai, CN
Sol-millennium Medical, Inc.
Chicago, IL, US
Zapalign Llc
Fort Lauderdale, FL, US
Shanghai Kindly Enterprise Development Group Co., Ltd.
JIADING Shanghai, CN
Rhino Medical Supply Inc
Columbia, SC, US
Zhejiang Longde Pharmaceutical Co., Ltd
HANGZHOU Zhejiang, CN
Toc Logistics / Sol-millenium Canada, Inc.
Maple Ontario, CA
Goldstar Medical Instruments
SIALKOT Punjab, PK
Retractable Technologies, Inc.
Little Elm, TX, US
Duopross Meditech Corporation
FARMINGDALE, NY, US
Cbr Enterprise Limited
Hong Kong, HK
Sterigenics Us Llc
Fort Worth, TX, US
Toc Logistics / Sol-millenium Canada, Inc.
Balzac Alberta, CA
Cmt Health Pte. Ltd.
Singapore, SG
Roncadelle Operations Srl
Castel Mella Brescia, IT
Jiangsu Caina Medical Co., Ltd
Jiangyin Jiangsu, CN
Bd Medical
HOLDREGE, NE, US
Promisemed Hangzhou Meditech Co.,ltd.
Hangzhou Zhejiang, CN
Jiangsu Micsafe Medical Technology Co., Ltd
Yancheng Jiangsu, CN
Ningbo Risenmed Technology Co.,ltd.
Ningbo Zhejiang, CN
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Terumo Medical Canada, Inc.
Vaughan Ontario, CA
510(k) clearances
162 clearances for this product code
- Methyl Co., Ltd.Feb 18, 2026
K252098 · PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
- Vault Paragon Group, Inc.Dec 12, 2025
K250847 · VaporShield
- Suzhou Savicred Biotechnology Co., Ltd.Nov 21, 2023
K230287 · SaviSafe Safety Device
- Shina Med CorporationOct 27, 2023
K231165 · Shina Syringe; Shina Safety Syringe
- Medline Industries, LPOct 18, 2023
K231907 · Medline Safety Insulin and TB Syringes
- Cardinal Health200, LLCJun 21, 2023
K223376 · Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)
- Vault Paragon Group, Inc.Jan 25, 2023
K220114 · PowerPAK Syringe
- Roncadelle Operations SrlDec 29, 2022
K221981 · SafeR Syringe and SafeR Sting