Syringe, Antistick
FDA product code MEG · Class II (moderate risk) · 21 CFR 880.5860 · General Hospital
162510(k) clearances
0PMA approvals
13recalls
Manufacturers
- Safety Syringes, Inc. 7
- M.K. Meditech Co. , Ltd. 5
- Life-Shield Products, Inc. 5
- Shantou Wealy Medical Instrument Co.,Ltd 4
- Biotop Technology Co., Ltd. 4
- Taiject Medical Device Co., Ltd. 4
- Retractable Technologies, Inc. 4
- Smiths Medical ASD Inc. 3
- Inviro Medical Devices, Inc. 3
- Formosa Medical Devices, Inc. 3
- Univec, Inc. 2
- Exelint Intl. Co. 2
- Sta-Med, LLC 2
- New Medical Technology , Ltd. 2
- Ultimed, Inc. 2
- Inviro Medical 2
- Unilife Medical Solutions Limited 2
- Medline Industries, LP 2
- Safety Medical International, Incorporated 2
- Medical Device Manufacturer (Thailand) , Ltd. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)MEG · Traditional | Methyl Co., Ltd. | 02/18/2026SE |
| K250847 | VaporShieldMEG · Traditional | Vault Paragon Group, Inc. | 12/12/2025SE |
| K230287 | SaviSafe Safety DeviceMEG · Traditional | Suzhou Savicred Biotechnology Co., Ltd. | 11/21/2023SE |
| K231165 | Shina Syringe; Shina Safety SyringeMEG · Traditional | Shina Med Corporation | 10/27/2023SE |
| K231907 | Medline Safety Insulin and TB SyringesMEG · Traditional | Medline Industries, LP | 10/18/2023SE |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan…MEG · Abbreviated | Cardinal Health200, LLC | 06/21/2023SE |
| K220114 | PowerPAK SyringeMEG · Traditional | Vault Paragon Group, Inc. | 01/25/2023SE |
| K221981 | SafeR Syringe and SafeR StingMEG · Traditional | Roncadelle Operations Srl | 12/29/2022SE |
| K222452 | Disposable Automatically Retractable Safety Syringes (with detachable needle)MEG · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 11/23/2022SE |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…MEG · Traditional | Jiangsu Kangbao Medical Equipment Co., Ltd. | 11/01/2022SE |
| K220057 | Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for…MEG · Traditional | Shinva Ande Healthcare Apparatus Co., Ltd. | 10/07/2022SE |
| K221073 | Sterile Hypodermic Syringes for Single Use with Safety NeedlesMEG · Traditional | Sichuan Prius Biotechnology Co., Ltd. | 10/04/2022SE |
| K220061 | Safety Insulin SyringesMEG · Traditional | Berpu Medical Technology Co., Ltd. | 08/23/2022SE |
| K212518 | Jeesung Safety Syringe and Single Use NeedlesMEG · Special | Jeesung Medical Co., Ltd. | 08/18/2022SE |
| K213077 | Automatically Retractable Safety SyringeMEG · Traditional | Zhejiang Lingyang Medical Apparatus Co., Ltd. | 04/27/2022SE |
| K210216 | Disposable Automatically Retractable Insulin Safety SyringeMEG · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 03/04/2022SE |
| K212652 | Sterile Syringe with Fixed Safety Needle for Single UseMEG · Traditional | Gemtier Medical (Shanghai), Inc. | 03/02/2022SE |
| K211484 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle…MEG · Traditional | Shinva Ande Healthcare Apparatus Co., Ltd. | 03/01/2022SE |
| K212949 | Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for…MEG · Abbreviated | Henan Nursecare Biotechnology Co., Ltd. | 02/24/2022SE |
| K210229 | Sterile Auto-Disable Syringes with/without Needle for Single UseMEG · Traditional | Zhejiang Kangkang Medical-Devices Co., Ltd. | 02/15/2022SE |
| K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle…MEG · Traditional | Jiangsu Kangbao Medical Equipment Co., Ltd. | 11/15/2021SE |
| K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with SyringeMEG · Traditional | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 10/18/2021SE |
| K211753 | Sterile Syringe With Safety NeedleMEG · Traditional | Jiangxi Hongda Medical Equipment Group , Ltd. | 10/14/2021SE |
| K212226 | DR Safety Syringe, Sterile Hypodermic needle for Single useMEG · Traditional | Zhuhai DR Medical Instruments Co., Ltd. | 09/29/2021SE |
| K202570 | Insulin Syringe, Insulin Syringe with Safety RetractableMEG · Traditional | Jiangsu Micsafe Medical Technology Co., Ltd. | 07/02/2021SE |
| K191639 | TK Insulin Syringe with/without Saftey Retractable DeviceMEG · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 09/11/2020SE |
| K193022 | Retractable Safety Insulin SyringeMEG · Traditional | Jiangsu Caina Medical Co.,Ltd | 07/20/2020SE |
| K192679 | Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use…MEG · Traditional | Gemtier Medical (Shanghai), Inc. | 04/10/2020SE |
| K190183 | Hypodermic Safety Needle, Hypodermic Safety Needle with SyringeMEG · Traditional | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 10/04/2019SE |
| K191490 | Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety…MEG · Traditional | Jiangsu Caina Medical Co.,Ltd | 10/03/2019SE |
| K183665 | Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe…MEG · Traditional | Jiangsu Micsafe Medical Technology Co., Ltd. | 09/06/2019SE |
| K173743 | Greenmedi Safety Filter SyringeMEG · Traditional | Sang-A Frontec Co., Ltd. | 01/28/2019SE |
| K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single…MEG · Traditional | Berpu Medical Technology Co., Ltd. | 08/09/2018SE |
| K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…MEG · Traditional | Yangzhou Medline Industry, Co., Ltd. | 08/02/2017SE |
| K163162 | Sterile Hypodermic Safety Syringes for Single UseMEG · Traditional | Jiangxi Hongda Medical Equipment Group , Ltd. | 03/20/2017SE |
| K163511 | NovaGuard SA Pro Safety SystemMEG · Special | West Pharmaceutical Services, Inc. | 02/02/2017SE |
| K162030 | 0.5ml Sol-Care Retractable Safety Syringe with Fixed NeedleMEG · Special | Sol-Millennium Medical, Inc. | 08/19/2016SE |
| K152606 | Jeesung Safety Syringe and Single Use NeedlesMEG · Traditional | Jeesung Medical Co., Ltd. | 06/28/2016SE |
| K152808 | U&U Insulin Syringe with/without Safety Retractable DeviceMEG · Traditional | U&U Medical Technology Co, Ltd. | 03/25/2016SE |
| K143497 | Safety Auto-Disable Syrine with Needle (Auto-Lock)MEG · Traditional | Guangdong Intmed Medical Appliance Co., Ltd. | 11/04/2015SE |
| K143070 | Disposable Safety Self-destructive Syringes, 5 MLMEG · Traditional | Jiangsu Yile Medical Article Co., Ltd. | 07/07/2015SE |
| K150562 | Safe'n'Sound Staked Passive Delivery System - Plajex versionMEG · Abbreviated | Nemera | 06/02/2015SE |
| K141349 | Disposable sterile needle retractable safety syringeMEG · Traditional | Guangdong Haiou Medical Apparatus Stock Co., Ltd. | 04/10/2015SE |
| K142435 | 3S Safety Syringe with/without NeedleMEG · Traditional | Sincere Medical Device Co., Ltd. | 02/20/2015SE |
| K142436 | 3S Safety Insulin SyringeMEG · Traditional | Sincere Medical Device Co., Ltd. | 02/19/2015SE |
| K140949 | Ulticare Safety Syringe with Removable NeedleMEG · Traditional | Ultimed Incorporated | 02/09/2015SE |
| K141640 | Automatically Retractable Safety Syringes with Fixed NeedleMEG · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 11/19/2014SE |
| K141664 | Safe'N'Sound Staked Passive Delivery System - Cone VersionMEG · Abbreviated | Rexam Healthcare | 10/02/2014SE |
| K141464 | Novaguard S a Safety SystemMEG · Traditional | West Pharmaceutical Services | 09/10/2014SE |
| K132681 | Sol-Guard Insulin and Tuberculin Safety SyringeMEG · Traditional | Sol-Millennium Medical, Inc. | 05/22/2014SE |
| K131531 | Tiankang Disposable Syringes with Re-Use Prevention Feature with or Without NeedleMEG · Traditional | Anhui Tiankang Medical Products Co., Ltd. | 05/12/2014SE |
| K123743 | Ultrasafe Plus Passive Needle GuardMEG · Traditional | Safety Syringes, Inc. | 03/26/2013SE |
| K121637 | Auto-Disable Sterile Safty Syring for Single UseMEG · Traditional | Sunwell Biotech Co., Ltd. | 10/25/2012SE |
| K120641 | Global Medi Products Retractable Safety SyringeMEG · Traditional | Global Medi Products | 10/17/2012SE |
| K122558 | Ultrasafe Passive Needle GuardMEG · Special | Safety Syringes, Inc. | 09/20/2012SE |
| K113587 | Automatically Retractable Safety Syringe (with Fixed Needle)MEG · Traditional | Shantou Wealy Medical Instrument Co.,Ltd | 02/24/2012SE |
| K112936 | Safe'Sound Luer Lock Passive Devlivery SystemMEG · Abbreviated | Rexam Consummer Plastics Inc.D/B/A Rexam Pharma | 01/20/2012SE |
| K111734 | Mysafety SyringeMEG · Special | Medicalchain Intl. Corp. | 09/06/2011SE |
| K101560 | Medline Retractable Safety SyringeMEG · Abbreviated | Medline Industries, Inc. | 03/25/2011SE |
| K101233 | Safe'N'Sound Passive Delivery SystemMEG · Abbreviated | Rexam Pharma | 02/18/2011SE |
| K103781 | Med-Lok Safety NeedleMEG · Special | Sta-Med, LLC | 02/08/2011SE |
| K103011 | Ulticare Safety Insulin SyringeMEG · Traditional | Ulti-Med Intl., Inc. | 02/02/2011SE |
| K100998 | 1ML Unitract 27G X 1/2 Tuberculin Syringe, Model 132BY2-1MEG · Traditional | Unilife Medical Solutions Limited | 08/30/2010SE |
| K093176 | Med-LokMEG · Traditional | Sta-Med, LLC | 04/06/2010SE |
| K092430 | 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock…MEG · Special | Inviro Medical Devices, Inc. | 09/04/2009SE |
| K092413 | Invirosnap 50 and 100 Unit Insulin Safety SyringesMEG · Special | Inviro Medical Devices, Inc. | 09/04/2009SE |
| K080877 | 1ML Unitract Insulin Syringe 27G*1/2 , 1ML Unitract Syringe 29G*1/2MEG · Abbreviated | Unilife Medical Solutions Limited | 10/21/2008SE |
| K080600 | Ultimed Ulticare Safety SyringeMEG · Traditional | Ultimed, Inc. | 06/25/2008SE |
| K072739 | Jierui Syringes and NeedlesMEG · Traditional | Shandong Weigao Group Medical Polymer Co., Ltd. | 03/21/2008SE |
| K073206 | Needle-Trap/Needle Safety LabelMEG · Traditional | Schreiner Medipharm | 01/16/2008SE |
| K072482 | Hypodermic Needle-Pro Safety Allergy TrayMEG · Traditional | Smiths Medical Asd, Inc. | 11/29/2007SE |
| K072037 | Careo Safety Syringe for U-100 Insulin 0.5CC/MLMEG · Special | Life-Shield Products, Inc. | 08/08/2007SE |
| K070117 | Ssafe Plus Disposable Safety Syringe, 3 CC and 5 CCMEG · Traditional | Dolomite Biotech Sdn Bhd | 08/06/2007SE |
| K070203 | Invirosnap Safety Syringe, Models 120006, 120007, 120008, 100080, 130022, 130023 and…MEG · Special | Inviro Medical Devices, Inc. | 04/23/2007SE |
| K063340 | Saf-T-Syringe- 0.5 and 1ML/CCMEG · Traditional | Safety Medical International, Incorporated | 03/06/2007SE |
| K063755 | Portex Hypodermic Needle-Pro Fixed Needle SyringeMEG · Traditional | Smiths Medical Asd, Inc. | 02/27/2007SE |
| K062780 | Clickzip, Model U-100 Insulin Safety SyringeMEG · Abbreviated | Medical Device Manufacturer (Thailand) , Ltd. | 01/05/2007SE |
| K062318 | Biotop Hooksafe U-100 Insulin Syringe, Models 0.5CC/ML and 1CC/MLMEG · Traditional | Biotop Technology Co., Ltd. | 01/03/2007SE |
| K060971 | Omi Retractable Saftey Syringe, VariousMEG · Traditional | Omi Manufacturing Pty., Ltd. | 10/24/2006SE |
| K060772 | Manuel Saftey Syringe Parts 1 & 2MEG · Traditional | Medsafe Asa | 10/16/2006SE |
| K061194 | Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558MEG · Abbreviated | Smiths Medical Asd, Inc. | 08/24/2006SE |
| K053519 | Safety SyringeMEG · Traditional | Wuxi Yushou Medical Applicances Co., Ltd. | 08/11/2006SE |
| K061055 | Careo Safety Syringe for U-100 InsulinMEG · Abbreviated | Life-Shield Products, Inc. | 07/10/2006SE |
| K060668 | Safe Tip SyringeMEG · Traditional | Devon Safety Products, Inc. | 06/12/2006SE |
| K060002 | Ritract Safety SyringeMEG · Traditional | Ritract , Ltd. | 06/02/2006SE |
| K060109 | Omi Retractable Safety SyringeMEG · Traditional | Vitalcare Group, Inc. | 05/05/2006SE |
| K060743 | Modification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe Passive…MEG · Traditional | Safety Syringes, Inc. | 04/28/2006SE |
| K060208 | Careo Safety Syringe 1CC/ML, Models CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C…MEG · Special | Life-Shield Products, Inc. | 03/10/2006SE |
| K052397 | Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML)MEG · Traditional | Life-Shield Products, Inc. | 12/22/2005SE |
| K051694 | Clickzip Needle Retractable Safety SyringeMEG · Abbreviated | Medical Device Manufacturer (Thailand) , Ltd. | 12/21/2005SE |
| K051800 | IN6 Safety Syringe, Model 3MLMEG · Abbreviated | In6 Incuvestor, Inc. | 10/21/2005SE |
| K052103 | Exel Secure Touch II Safety SyringeMEG · Traditional | Exelint Intl. Co. | 10/19/2005SE |
| K051865 | Terumo Surguard 2 Safety Needle or SimilarMEG · Traditional | Terumo Medical Corp. | 09/27/2005SE |
| K051762 | Saf-T-Syringe/Saf-T-NeedleMEG · Traditional | Safety Medical International, Incorporated | 09/23/2005SE |
| K050116 | Uniqsafe Rotatable, Retractable Safety SyringesMEG · Traditional | Uniqsafe Biomeditech Co., Ltd. | 05/09/2005SE |
| K043419 | P&P Safety SyringeMEG · Traditional | Medexel Medical Mfg. Co., Ltd. | 04/15/2005SE |
| K050134 | Icc Insulin Safepro Safety SyringeMEG · Abbreviated | Formosa Medical Devices, Inc. | 04/05/2005SE |
| K050131 | Insosafe Bak'Snap Retractable Insulin Safety SyringeMEG · Traditional | M.K. Meditech Co. , Ltd. | 04/05/2005SE |
| K042102 | Yixin Safety SyringeMEG · Traditional | Jiangxi Sanxin (Eversincere) Medical Devices Group | 03/08/2005SE |
| K042487 | Procedur SF Safety Syringe DeviceMEG · Traditional | Avanca Medical Devices, Inc. | 01/21/2005SE |
| K043038 | Biotop Hooksafe Luer-Lock Safety Syringe, Models 3CC/ML, 5CC/ML and 10CC/MLMEG · Special | Biotop Technology Co., Ltd. | 12/22/2004SE |
| K042712 | Tamper Evident Ultrasafe Passive Delivery SystemMEG · Special | Safety Syringes, Inc. | 10/15/2004SE |
| K042426 | TMD 0.5ML Safety Syringe (FA18 Series 0.5ML/FA58 Series U-100 INSULIN/FA78 Series…MEG · Special | Taiject Medical Device Co., Ltd. | 09/22/2004SE |
| K041970 | Biotop Hooksafe Safety Syringe, Models 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML and 10CC/MLMEG · Special | Biotop Technology Co., Ltd. | 08/03/2004SE |
| K032517 | Medsafe Clicksafe Safety Antistick Syringe with Hypodermic NeedleMEG · Abbreviated | Medsafe Technologies, LLC | 05/18/2004SE |
| K032747 | Biotop Djt-A Safety SyringeMEG · Traditional | Biotop Technology Co., Ltd. | 05/11/2004SE |
| K030604 | Perfect Safety SyringeMEG · Traditional | Perfect Medical Industry Co., Ltd. | 04/30/2004SE |
| K040545 | Otter Safety SyringeMEG · Traditional | Otter (China) Technology Co., Ltd. | 04/22/2004SE |
| K040105 | Yue Pfong Safety Syringe (3ML)MEG · Traditional | Yue Pfong International Industrial Co., Ltd. | 04/07/2004SE |
| K040036 | Inviro Snap Safety Insulin Syringe, 1 CC, Model 102905MEG · Traditional | Inviro Medical | 03/18/2004SE |
| K034031 | 10 ML Bak'Snap Duopross Retractable Safety SyringeMEG · Special | M.K. Meditech Co. , Ltd. | 01/21/2004SE |
| K031909 | Betec Retractable Safety Syringe (5ML)MEG · Traditional | Betec Medical Science Co., Ltd. | 10/07/2003SE |
| K032247 | U.S. Technologies, Inc. Retractable Safety SyringeMEG · Traditional | U.S. Technologies, Inc. | 09/30/2003SE |
| K032780 | Inviro Snap Safety Syringe, 1CC, 3CC, 5CC, and 10CCMEG · Special | Inviro Medical | 09/24/2003SE |
| K031830 | Safepro Plus Safety SyringeMEG · Traditional | Formosa Medical Devices, Inc. | 08/05/2003SE |
| K031163 | Sez Safety SyringeMEG · Traditional | Sez Corporation | 07/08/2003SE |
| K031065 | Syringex Safety Syringe, Model 0322G1.5MEG · Traditional | Syringex Medical, Inc. | 06/23/2003SE |
| K031594 | Bak'Snap Duopro Safety Syring (Duopross) Safety'Tray Allergy Safety Syringe TrayMEG · Traditional | M.K. Meditech Co. , Ltd. | 06/06/2003SE |
| K030976 | Careo Retractable Safety SyringeMEG · Traditional | Life-Shield Products, Inc. | 05/30/2003SE |
| K031062 | TMD 1ML Safety Syringe (FA11 Series 1ML/FA51 Series U-100 INSULIN/FA71 Series Tuberculin)MEG · Special | Taiject Medical Device Co., Ltd. | 05/02/2003SE |
| K024249 | Terumo Surguard Safety SyringeMEG · Abbreviated | Terumo Medical Corp. | 02/21/2003SE |
| K011754 | Exel Securetouch PTP SyringeMEG · Traditional | Exelint Intl. Co. | 01/22/2003SE |
| K023458 | TMD Safety Syringe (FA14 Series 10ML/FA15 Series 20ML)MEG · Special | Taiject Medical Device Co., Ltd. | 11/07/2002SE |
| K023323 | 1CC Futura Safety SyringeMEG · Special | Futura Medical Technology | 10/29/2002SE |
| K022806 | Duopro Safety Syringe (Duopross)MEG · Special | M.K. Meditech Co. , Ltd. | 09/19/2002SE |
| K022278 | TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML)MEG · Traditional | Taiject Medical Device Co., Ltd. | 09/12/2002SE |
| K022063 | Safepro Safety SyringeMEG · Traditional | Formosa Medical Devices, Inc. | 08/29/2002SE |
| K020623 | Duopro Safety Syringe (Duopross)MEG · Traditional | M.K. Meditech Co. , Ltd. | 05/02/2002SE |
| K013006 | Ovus Capless Safety NeedleMEG · Traditional | Ovus Systems | 02/06/2002SE |
| K013801 | Ultrasafe Dental Injection SystemMEG · Special | Safety Syringes, Inc. | 12/13/2001SE |
| K010819 | 3CC NMT Safety SyringeMEG · Traditional | New Medical Technology , Ltd. | 11/08/2001SE |
| K012121 | Secureguard Retractable Safety SyringeMEG · Traditional | Safegard Medical Products, Inc. | 10/24/2001SE |
| K012726 | Prosafe Safety SyringeMEG · Traditional | Hou-Se Medical, Inc. | 10/18/2001SE |
| K010477 | Auto-LockMEG · Traditional | Auto-Lock | 10/09/2001SE |
| K003555 | Solo-Safe Safety Syringe, SIZE-3CCMEG · Traditional | Spectrum Biotech, Inc. | 08/29/2001SE |
| K011103 | BD Spring Based SyringeMEG · Traditional | Bd | 06/13/2001SE |
| K011369 | Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory)MEG · Traditional | Safety Syringes, Inc. | 05/29/2001SE |
| K003348 | E.N.S.I. Retractable Safety SyringeMEG · Traditional | Ensi-Med International Pty. , Ltd. | 01/12/2001SE |
| K993996 | Univec Auto-Disable Hypodermic SyringeMEG · Traditional | Univec, Inc. | 07/17/2000SE |
| K000860 | Futura Safety SyringeMEG · Abbreviated | Sheila W. Pickering | 06/30/2000SE |
| K001017 | Retrax Retracting Needle Syringe, Size 3CCMEG · Traditional | Retrax Safety Systems, Inc. | 06/02/2000SE |
| K993609 | Sologuard Locking Plus SyringeMEG · Traditional | Safeguard Medical Products, Inc. | 03/17/2000SE |
| K990831 | Superguard Safety SyringeMEG · Traditional | U.S. Safety Syringes Co., Inc. | 03/08/2000SE |
| K000572 | E.N.S.I. SyringeMEG · Traditional | Tri-Ject Intl. Corp. | 02/24/2000SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/01/1999SE |
| K990208 | Personal Infusor with Drug Disposal Septal PortMEG · Traditional | Science Incorporated | 03/25/1999SE |
| K982431 | NMT Safety SyringeMEG · Traditional | New Medical Technology , Ltd. | 11/18/1998SE |
| K973888 | Smartlock Safety SyringeMEG · Traditional | Medical Innovation , Ltd. | 06/03/1998SE |
| K971077 | Covertip Safety SyringeMEG · Traditional | Medisys Technologies, Inc. | 05/15/1998SE |
| K980069 | Vanishpoint SyringeMEG · Traditional | Retractable Technologies, Inc. | 02/12/1998SE |
| K973792 | Easysafe Retracting Needle SyringeMEG · Traditional | Saf-T-Med, Inc. | 01/29/1998SE |
| K973301 | Anti-Stick Syringe with Integral Hypodermic Needle/Vanishpoint SyringeMEG · Traditional | Retractable Technologies, Inc. | 11/07/1997SE |
| K970803 | Anti-Stick Syringe with Integral Hypodermic Needle Vanishpoint SyringeMEG · Traditional | Retractable Technologies, Inc. | 05/29/1997SE |
| K933469 | Univec Non-Reusable SyringeMEG · Traditional | Univec, Inc. | 04/18/1996SE |
| K946219 | Pop-N-Lok SyringeMEG · Traditional | Retractable Technologies, Inc. | 12/28/1995SE |
| K955030 | Square One Safety SyringeMEG · Traditional | Square One Medical, LP | 12/15/1995SE |
| K933569 | Pent Nova Autoblock SyringeMEG · Traditional | Medi-Hut Co., Inc. | 06/09/1995SE |
| K936225 | TS1 Turtle(Tm) SyringeMEG · Traditional | Kershenstine Diamond, Inc. | 05/16/1995SE |
| K936040 | Hypo(R) Safety Cartridge SyringeMEG · Traditional | Smith & Nephew, Inc. | 05/01/1995SE |
| K944425 | Ultrasafe Aspirating SyringeMEG · Traditional | Safety Syringes, Inc. | 01/26/1995SE |
| K941450 | Inviro SyringeMEG · Traditional | Dr. F. Ross Sharp , Ltd. | 12/12/1994SE |
| K925039 | Safesnap Safety SyringeMEG · Traditional | U.S. Medical Instruments, Inc. | 02/16/1994SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0310-2025 Class I | Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap… | Cardinal Health 200, LLC | 09/25/2024Open, Classified |
| Z-1507-2022 Class II | Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box…Complaints received in which needle and needle holder have detached from the syringe after injection as well… | Guangdong Haiou Medical Apparatus Co., Ltd | 06/10/2022Open, Classified |
| Z-1506-2022 Class II | HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch…Complaints received in which needle and needle holder have detached from the syringe after injection as well… | Guangdong Haiou Medical Apparatus Co., Ltd | 06/10/2022Open, Classified |
| Z-1798-2021 Class I | JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x…Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd… | Smiths Medical ASD Inc. | 05/17/2021Terminated |
| Z-0551-2016 Class II | Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product…Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with… | Terumo Medical Corp | 11/23/2015Terminated |
| Z-0646-2014 Class II | Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2…Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin… | Smiths Medical ASD, Inc. | 07/10/2013Terminated |
| Z-0645-2014 Class II | Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2…Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin… | Smiths Medical ASD, Inc. | 07/10/2013Terminated |
| Z-0644-2014 Class II | Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2…Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin… | Smiths Medical ASD, Inc. | 07/10/2013Terminated |
| Z-0643-2014 Class II | Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2…Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin… | Smiths Medical ASD, Inc. | 07/10/2013Terminated |
| Z-0642-2014 Class II | Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2…Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro Fixed Needle Insulin… | Smiths Medical ASD, Inc. | 07/10/2013Terminated |
| Z-1577-2013 Class II | BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is…There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe. | Becton Dickinson & Company | 05/01/2013Terminated |
| Z-1800-2010 | InviroSnap Retractable Safety Syringes, Rx Only, Single use, Sterile, Inviro Medical…Syringe Defects. Group 1 syringes: The plunger pull out force was below specification. Group 2 syringes: The… | Inviro Medical Devices, Inc | 05/10/2010Terminated |
| Z-0619-2009 | BD 1 ml Integra TB Syringe with Retracting Precision Glide Needle; 1 ml 27 g 1/2 (0.4mm…Expiry date on the shelf carton is incorrect. It reads 2013-13, it should read 2013-03. | Becton Dickinson & Company | 11/24/2008Terminated |