Endoscopic Injection Needle, Gastroenterology-Urology
FDA product code FBK · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
89510(k) clearances
0PMA approvals
41recalls
Manufacturers
- Carbon Medical Technologies, Inc. 5
- Wilson-Cook Medical, Inc. 4
- Boston Scientific Corporation 4
- Mill-Rose Laboratory 3
- Advanced Uroscience, Inc. 3
- Enteric Medical Technologies 3
- Olympus Medical Systems Corp. 3
- Uroplasty, Inc. 3
- Laborie Medical Technologies, Ltd. 2
- United States Endoscopy Group, Inc. 2
- C.R. Bard, Inc. 2
- Endovations 2
- Cook Urological, Inc. 2
- Medi-Globe Corp. 2
- Endochoice, Inc. 2
- Wiltek Medical, Inc. 1
- Mirco-Tech (Nanjing) Co., Ltd. 1
- Olympus Corp. 1
- Surgitek Medical Engineering Corp. 1
- Urologic Surgical Devices Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260262 | Injection NeedleFBK · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 05/29/2026SE |
| K253598 | InjecSURE Injection SystemFBK · Traditional | Carbon Medical Technologies, Inc. | 03/31/2026SE |
| K252021 | Disposable Endoscopic Injection NeedlesFBK · Traditional | Changzhou New Med Micro-Medtech Co., Ltd. | 12/02/2025SE |
| K252247 | Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector…FBK · Traditional | Olympus Medical Systems Corporation | 10/16/2025SE |
| K241595 | EzVu Visual Vasopressor injector (EV-19)FBK · Traditional | Veol Medical Technologies Pvt , Ltd. | 02/27/2025SE |
| K240675 | Endoscopic Injection NeedlesFBK · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 10/04/2024SE |
| K241523 | injeTAK Adjustable Tip Needle (DIS199; DIS201)FBK · Special | Laborie Medical Technologies, Corp. | 08/27/2024SE |
| K232200 | Disposable Injection NeedlesFBK · Traditional | Ningbo Xinwell Medical Technology Co., Ltd. | 04/12/2024SE |
| K232826 | Articulator Injection Needle (00711807), Articulator Injection Needle (00711810)…FBK · Traditional | Steris | 03/08/2024SE |
| K232442 | Disposable Endoscope Injection NeedlesFBK · Traditional | Zhejiang Soudon Medical Technology Co., Ltd. | 11/09/2023SE |
| K230925 | Disposable Injection Needle AF seriesFBK · Traditional | Alton (Shanghai) Medical Instruments Co., Ltd. | 09/27/2023SE |
| K222006 | Sclerotherapy & Endoscopic NeedlesFBK · Traditional | G-Flex Europe Sprl | 04/03/2023SE |
| K221054 | Core-InjectorFBK · Traditional | Incore Co., Ltd. | 12/21/2022SE |
| K221085 | LiNA OperaScope NeedleFBK · Traditional | Lina Medical Aps | 09/02/2022SE |
| K220292 | Disposable Endoscope Injection NeedleFBK · Traditional | Yangzhou Fartley Medical Instrument Technology… | 08/19/2022SE |
| K213914 | Injection NeedleFBK · Traditional | Jiangsu Vedkang Medical Science and Technology… | 07/29/2022SE |
| K213239 | Endoscopic Injection NeedleFBK · Traditional | Beijing Zksk Technology Co., Ltd. | 06/02/2022SE |
| K212668 | Sclerotherapy NeedleFBK · Traditional | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 02/23/2022SE |
| K210917 | Single Use Injection NeedleFBK · Traditional | Anrei Medical (Hangzhou) Co., Ltd. | 05/28/2021SE |
| K192498 | Single Use InjectorFBK · Traditional | Olympus Medical Systems Corp. | 04/28/2020SE |
| K190032 | Disposable Sclerotherapy NeedleFBK · Traditional | Hangzhou AGS MedTech Co., Ltd. | 02/27/2020SE |
| K190829 | Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI)FBK · Traditional | Wilson-Cook Medical Inc./Cook Endoscopy | 12/19/2019SE |
| K181690 | Clear-Jet Injection CatheterFBK · Traditional | Finemedix Co., Ltd. | 12/21/2018SE |
| K180214 | Repris Bladder Injection SystemFBK · Traditional | Uro-1, Inc. | 05/03/2018SE |
| K172227 | Endoscopic Injection NeedleFBK · Special | Carbon Medical Technologies, Inc. | 08/23/2017SE |
| K171602 | Williams Cystoscopic Injection NeedleFBK · Traditional | Cook Incorporated | 07/28/2017SE |
| K171454 | Interject Injection Therapy Needle CatheterFBK · Traditional | Boston Scientific Corporation | 07/07/2017SE |
| K153625 | Single Use Injector NM600/610FBK · Traditional | Olympus Medical Systems Corp. | 02/12/2016SE |
| K151475 | EndoChoice Select Injection NeedleFBK · Traditional | Endochoice, Inc. | 02/08/2016SE |
| K152035 | iSnare system-LariatFBK · Traditional | United States Endoscopy Group, Inc. | 10/15/2015SE |
| K150434 | Injection NeedleFBK · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 06/02/2015SE |
| K142144 | Disposable Injection NeedleFBK · Traditional | Wilson Instruments (Shanghai) Company Limited | 01/15/2015SE |
| K133148 | Biomarc Coaxial NeedleFBK · Traditional | Carbon Medical Technologies, Inc. | 05/13/2014SE |
| K132065 | Injection NeedleFBK · Traditional | Endochoice, Inc. | 01/17/2014SE |
| K121337 | Uroplasty Rigid Endoscpic NeedlesFBK · Traditional | Uroplasty, Inc. | 08/03/2012SE |
| K113634 | Injekt Cysto Flexible Injection NeedleFBK · Special | Cook Ireland, Ltd. | 02/14/2012SE |
| K111495 | Cook Gi Endoscopic Injection Gel Kit, Gel-S, Gel-N, Gel-H, Gel-KFBK · Traditional | Wilson-Cook Medical, Inc. | 07/19/2011SE |
| K092090 | Erbelift Hand Pump and Flexible ProbeFBK · Traditional | Byrne Medical, Inc. | 11/30/2009SE |
| K090830 | Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid TipFBK · Traditional | Laborie Medical Technologies, Ltd. | 07/21/2009SE |
| K091391 | Uroplasty Rigid Endoscopic Needle, MRN-518FBK · Traditional | Uroplasty, Inc. | 06/30/2009SE |
| K090217 | Bonee Needle for Bladder Injections, MODELSNBI035, NBI070FBK · Traditional | Coloplast A/S | 04/23/2009SE |
| K082319 | Injekt Filiform Injection NeedleFBK · Traditional | Cook Urological, Inc. | 09/25/2008SE |
| K061222 | Injectra Injection NeedleFBK · Traditional | Medi-Globe Corp. | 07/03/2006SE |
| K043383 | N-Do Endoinjector Needle, Model PH00961109 and PH00961110FBK · Traditional | Physion, Inc. | 10/27/2005SE |
| K051905 | Uroplasty Rigid Endoscopic NeedleFBK · Traditional | Uroplasty, Inc. | 08/29/2005SE |
| K050688 | Tegress Implant NeedleFBK · Special | C.R. Bard, Inc. | 04/06/2005SE |
| K042882 | Enteryx Injection CatheterFBK · Special | Boston Scientific Corp | 11/09/2004SE |
| K042615 | Carbon Medical Technologies Endoscopic Injection NeedleFBK · Traditional | Carbon Medical Technologies, Inc. | 11/05/2004SE |
| K031238 | Varices NeedleFBK · Traditional | Scandimed. A.S. | 10/04/2004SE |
| K030451 | Carbon Medical Technologies Injection NeedleFBK · Traditional | Carbon Medical Technologies, Inc. | 04/30/2003SE |
| K022484 | Cook Injection NeedleFBK · Traditional | Cook Urological, Inc. | 10/25/2002SE |
| K013712 | Enteryx InjectorFBK · Traditional | Enteric Medical Technologies | 05/31/2002SE |
| K012977 | Varices Injection NeedleFBK · Traditional | Endo-Therapeutics, Inc. | 11/02/2001SE |
| K011484 | Olympus Injector NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1FBK · Traditional | Olympus Optical Co., Ltd. | 08/10/2001SE |
| K010448 | Horizons International Varices Injection NeedlesFBK · Traditional | Horizons Intl. Corp. | 05/16/2001SE |
| K002778 | Enteric Injection Catheter with IrrigationFBK · Traditional | Enteric Medical Technologies, Inc. | 11/22/2000SE |
| K002573 | Advanced Uroscience InnersheathFBK · Traditional | Advanced Uroscience, Inc. | 11/16/2000SE |
| K002323 | Advanced Uroscience Injection NeedleFBK · Special | Advanced Uroscience, Inc. | 07/31/2000SE |
| K001146 | Genyx Flexible Injection NeeedleFBK · Traditional | Geny Medical, Inc. | 06/30/2000SE |
| K000646 | Disposable Injector or Disposable Sclerotherapy NeedleFBK · Traditional | Enteric Medical Technologies | 04/13/2000SE |
| K990996 | Genyx Medical Injection NeedleFBK · Traditional | Genyx Medical, Inc. | 06/18/1999SE |
| K983765 | Injection Needle Probe/Device-TunisFBK · Traditional | Ximed/Prosure/Injectx | 12/11/1998SE |
| K982890 | Advanced Uroscience Injection NeedleFBK · Traditional | Advanced Uroscience, Inc. | 10/26/1998SE |
| K961846 | Needle CatheterFBK · Traditional | Boston Scientific Corp | 07/15/1996SE |
| K960519 | Martech Endoscopic Injection NeedleFBK · Traditional | Martech Medical Products, Inc. | 05/01/1996SE |
| K955558 | Gip/Medi-Globe Sclerotherapy NeedlesFBK · Traditional | Medi-Globe Corp. | 02/29/1996SE |
| K954519 | Wang Transendoscopic Aspiration NeedleFBK · Traditional | Mill-Rose Laboratory | 12/22/1995SE |
| K953441 | Riza-Ribe NeedleFBK · Traditional | R-Med, Inc. | 08/18/1995SE |
| K953338 | Injection NeedleFBK · Traditional | Boston Scientific Corp | 08/02/1995SE |
| K951648 | Mist Endoscopic NeedlesFBK · Traditional | Mist, Inc. | 05/12/1995SE |
| K950976 | Karl Storz Adult and Pediatric Viscous Fluid Injection SetsFBK · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/21/1995SE |
| K941305 | Wilson-Cook Variable Length Gi Injection NeedleFBK · Traditional | Wilson-Cook Medical, Inc. | 06/02/1994SE |
| K933815 | Bard Endoscopic Injection SystemFBK · Traditional | C.R. Bard, Inc. | 12/01/1993SE |
| K921800 | Colonoscopic Injection Needle, C-323/C-325FBK · Traditional | Mill-Rose Laboratory | 02/08/1993SE |
| K924102 | NeedleFBK · Traditional | United States Endoscopy Group, Inc. | 11/25/1992SE |
| K914496 | Sclerotherapy NeedleFBK · Traditional | Surgitek Medical Engineering Corp. | 12/05/1991SE |
| K903668 | Wilson-Cook Aspiration HandleFBK · Traditional | Wilson-Cook Medical, Inc. | 10/15/1990SE |
| K902736 | NM Injection NeedlesFBK · Traditional | Olympus Corp. | 08/24/1990SE |
| K901437 | Transendoscopic Sclerotheraphy NeedleFBK · Traditional | Telemed Systems, Inc. | 06/18/1990SE |
| K896424 | Porges Sclerotherapy NeedlesFBK · Traditional | Porges Corp. | 01/26/1990SE |
| K894868 | Wiltek Varices Injection NeedleFBK · Traditional | Wiltek Medical, Inc. | 12/21/1989SE |
| K883093 | Transendoscopic Aspiration NeedleFBK · Traditional | Endovations | 12/08/1988SE |
| K872060 | Washing/Injection NeedleFBK · Traditional | Endovations | 07/21/1987SE |
| K865086 | Williams Flexible Cystoscopic Injection NeedleFBK · Traditional | Van-Tec, Inc. | 03/10/1987SE |
| K855176 | Transurethal Prostatome Diag Treatm Propulsion SysFBK · Traditional | Urologic Surgical Devices Corp. | 05/13/1986SE |
| K851952 | Varices InjectorFBK · Traditional | Wilson-Cook Medical, Inc. | 07/26/1985SE |
| K834403 | Injection NeedleFBK · Traditional | Bobbs Medical, Inc. | 02/04/1984SE |
| K820973 | Endoscopic Injection NeedleFBK · Traditional | Mill-Rose Laboratory | 04/16/1982SE |
| K812057 | Vance CystoscopicFBK · Traditional | Vance Products, Inc. | 07/31/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0476-2025 Class II | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that… | Hobbs Medical, Inc. | 10/04/2024Open, Classified |
| Z-0475-2025 Class II | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that… | Hobbs Medical, Inc. | 10/04/2024Open, Classified |
| Z-0474-2025 Class II | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that… | Hobbs Medical, Inc. | 10/04/2024Open, Classified |
| Z-0473-2025 Class II | Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that… | Hobbs Medical, Inc. | 10/04/2024Open, Classified |
| Z-0472-2025 Class II | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that… | Hobbs Medical, Inc. | 10/04/2024Open, Classified |
| Z-0471-2025 Class II | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that… | Hobbs Medical, Inc. | 10/04/2024Open, Classified |
| Z-0470-2025 Class II | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that… | Hobbs Medical, Inc. | 10/04/2024Open, Classified |
| Z-0469-2025 Class II | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that… | Hobbs Medical, Inc. | 10/04/2024Open, Classified |
| Z-0468-2025 Class II | Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that… | Hobbs Medical, Inc. | 10/04/2024Open, Classified |
| Z-0572-2024 Class II | Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182AThe efficacy of the manual cleaning process cannot be assured for the affected injection needles intended… | Karl Storz Endoscopy | 10/24/2023Open, Classified |
| Z-1478-2023 Class II | injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length…The packaging may be damaged, compromising the sterile barrier. | Labories Medical Technologies | 02/07/2023Open, Classified |
| Z-0226-2023 Class II | ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic…***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions***… | Boston Scientific Corporation | 10/10/2022Open, Classified |
| Z-0225-2023 Class II | ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal…***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions***… | Boston Scientific Corporation | 10/10/2022Open, Classified |
| Z-0025-2023 Class II | Hobbs Posi-Stop Injection Needle Catalog Number: 4722Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0024-2023 Class II | Hobbs Posi-Stop Injection Needle Catalog Number: 4720Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0023-2023 Class II | Hobbs Posi-Stop Injection Needle Catalog Number: 4718Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0022-2023 Class II | Hobbs Posi-Stop Injection Needle Catalog Number: 4712Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0021-2023 Class II | Hobbs Posi-Stop Injection Needle Catalog Number: 4704Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-0020-2023 Class II | Hobbs Posi-Stop Injection Needle Catalog Number: 4702Device label display an incorrect expiration date, extends the shelf life of the product. Affected product… | Hobbs Medical, Inc. | 07/29/2022Open, Classified |
| Z-1049-2021 Class II | NEEDLEMASTER 1.8MMx 26G LOWER, model no. NM-610U-1826 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1048-2021 Class II | NEEDLEMASTER 6MMx 25G LOWER, model no. NM-610U-0625 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1047-2021 Class II | NEEDLEMASTER 6MMx 23G LOWER, model no. NM-610U-0623 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1046-2021 Class II | NEEDLEMASTER 5MMx 25G LOWER, model no. NM-610U-0525 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1045-2021 Class II | NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0523 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1044-2021 Class II | NEEDLEMASTER 4MMx 26G LOWER, model no. NM-610U-0426 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1043-2021 Class II | NEEDLEMASTER 4MMx 25G LOWER, model no. NM-610U-0425 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1042-2021 Class II | NEEDLEMASTER 4MMx 23G LOWER, model no. NM-610U-0423 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1041-2021 Class II | NEEDLEMASTER 3MMx 26G LOWER, model no. NM-610U-0326 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1040-2021 Class II | NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610U-0323 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1039-2021 Class II | NEEDLEMASTER 6MMx 25G UPPER, model no. NM-610L-0625 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1038-2021 Class II | NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1037-2021 Class II | NEEDLEMASTER 6MMx 21G UPPER, model no. NM-610L-0621 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1036-2021 Class II | NEEDLEMASTER 5MMx 25G UPPER, model no. NM-610L-0525 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1035-2021 Class II | NEEDLEMASTER 3MMx 23G LOWER, model no. NM-610L-0523 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1034-2021 Class II | NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1033-2021 Class II | NEEDLEMASTER 4MMx 26G UPPER, model no. NM-610L-0426 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1032-2021 Class II | NEEDLEMASTER 4MMx 25G UPPER, model no. NM-610L-0425 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1031-2021 Class II | NEEDLEMASTER 4MMx 23G UPPER, model no. NM-610L-0423 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-1030-2021 Class II | NEEDLEMASTER 4MMx 21G UPPER, model no. NM-610L-0421 - Product Usage: Used with…Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat… | Aomori Olympus Co., Ltd. | 01/04/2021Terminated |
| Z-2089-2019 Class II | Acuject Variable Injection NeedlePotential for occluded injection needles. | Wilson-Cook Medical Inc. | 06/14/2019Terminated |
| Z-0289-2017 Class II | Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile…US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was… | US Endoscopy Group Inc | 05/18/2016Terminated |