Endoscopic Injection Needle, Gastroenterology-urology
Gastroenterology, Urology · 21 CFR 876.1500
inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Recent MDR events
570 adverse event reports on file
- SINGLE USE INJECTORJul 20, 2026MalfunctionOlympus Vietnam Co. Ltd.3008040402-2026-00259
- SINGLE USE INJECTORJul 20, 2026MalfunctionOlympus Vietnam Co. Ltd.3008040402-2026-00260
- NAJul 16, 2026MalfunctionUs Endoscopy1528319-2026-00083
- SINGLE USE INJECTORJul 9, 2026MalfunctionAomori Olympus Co., Ltd.9614641-2026-00729
- ACUJECT VARIABLE INJECTION NEEDLEJul 7, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00323
- ACUJECT VARIABLE INJECTION NEEDLEJul 7, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00324
- ACUJECT VARIABLE INJECTION NEEDLEJul 1, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00308
- INTERJECTJun 15, 2026MalfunctionBoston Scientific Corporation3005099803-2026-02446
- ACUJECT VARIABLE INJECTION NEEDLEJun 11, 2026MalfunctionWilson-cook Medical Inc1037905-2026-00275
- NAJun 10, 2026MalfunctionUs Endoscopy1528319-2026-00065
Event type breakdown
Recalls
42 recall events for this product code
- Hobbs Medical, Inc.Open, ClassifiedNov 15, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Z-0468-2025 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedNov 15, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Z-0469-2025 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedNov 15, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Z-0470-2025 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedNov 15, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Z-0471-2025 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedNov 15, 2024
Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Z-0472-2025 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedNov 15, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Z-0473-2025 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedNov 15, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Z-0474-2025 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedNov 15, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Z-0475-2025 · View FDA record ↗ - Hobbs Medical, Inc.Open, ClassifiedNov 15, 2024
Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4723
Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigations that some units contained debris from the manufacturing process within the inner sheath that blocked the ID of the needle.
Z-0476-2025 · View FDA record ↗ - Karl Storz EndoscopyOpen, ClassifiedDec 18, 2023
Injection Needle, 3 Fr., REF: 27030N; Injection Cannula, 6 Fr., REF: 27182A
The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.
Z-0572-2024 · View FDA record ↗
Registered firms
131 firms currently registered for this product code
United States Endoscopy Group, Inc.
Mentor, OH, US
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Gyrus Acmi, Inc.
Brooklyn Park, MN, US
Boston Scientific Corporation
Coventry, RI, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Lina Medical Aps
Naerum Hovedstaden, DK
Changzhou Jiuhong Medical Instrument Co., Ltd.
CHANGZHOU Jiangsu, CN
Bioteque Corporation I-lan Factory Ii
Su-Ao Cheng Yilan, TW
Cook Incorporated
Spencer, IN, US
Cook Incorporated
Bloomington, IN, US
Steritec Services, Llc
ATHENS, TX, US
Sterigenics U.s., Llc
Salt Lake City, UT, US
Bq Plus Medical Co.,ltd
SONGJIANG Shanghai, CN
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Sklar Corporation - Warehouse
Salisbury, MD, US
Uro-1, Inc.
Greensboro, NC, US
Beijing Zksk Technology Co., Ltd.
beijing, CN
Lina Medical Polska Sp. Z O.o
Tarnowo Podgorne Wielkopolskie, PL
Pharmco Medical Bv
ROTTERDAM Zuid-Holland, NL
Diversatek Healthcare Inc
Milwaukee, WI, US
Zhejiang Soudon Medical Technology Co.,ltd
Hangzhou Zhejiang, CN
Jiangsu Vedkang Medical Science And Technology Co.,ltd.
Changzhou Jiangsu, CN
510(k) clearances
89 clearances for this product code
- Mirco-Tech (Nanjing) Co., Ltd.May 29, 2026
K260262 · Injection Needle
- Carbon Medical Technologies, Inc.Mar 31, 2026
K253598 · InjecSURE Injection System
- Changzhou New Med Micro-Medtech Co., Ltd.Dec 2, 2025
K252021 · Disposable Endoscopic Injection Needles
- Olympus Medical Systems CorporationOct 16, 2025
K252247 · Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)
- Veol Medical Technologies Pvt , Ltd.Feb 27, 2025
K241595 · EzVu Visual Vasopressor injector (EV-19)
- Promisemed Hangzhou Meditech Co., Ltd.Oct 4, 2024
K240675 · Endoscopic Injection Needles
- Laborie Medical Technologies, Corp.Aug 27, 2024
K241523 · injeTAK Adjustable Tip Needle (DIS199; DIS201)
- Ningbo Xinwell Medical Technology Co., Ltd.Apr 12, 2024
K232200 · Disposable Injection Needles