Syringe, Irrigating (non Dental)
General Hospital · 21 CFR 880.6960
Recent MDR events
586 adverse event reports on file
- DOVERJul 9, 2026InjuryCardinal Health 200, Llc1423537-2026-00228
- DOVERJul 2, 2026MalfunctionCardinal Health25689699
- MONOJECTJun 12, 2026MalfunctionCardinal Health 200, Llc25484929
- MEDLINEJun 12, 2026MalfunctionMedline Industries, Inc.25485279
- MEDLINEMay 20, 2026MalfunctionMedline Industries, Lp1417592-2026-01533
- SYRINGE CATHETER TIP 50MLApr 8, 2026MalfunctionBd Medical (bd West) Medical Surgical1911916-2026-00163
- OTO-TIP EARWAX REMOVAL TOOLApr 8, 2026InjuryPneo Llc.MW5186484
- MEDLINEMar 20, 2026InjuryMedline Industries Lp1417592-2026-00236
- MEDLINEMar 10, 2026MalfunctionMedline Industries, Lp1417592-2026-00200
- SYRINGE 50ML CATHETER TIP BRAZILFeb 20, 2026MalfunctionBd Medical (bd West) Medical Surgical1911916-2026-00077
Event type breakdown
Recalls
20 recall events for this product code
- Boston Scientific CorporationOpen, ClassifiedJul 10, 2026
Rapid Refill Continuous Injection System, UPN M00566001
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.
Z-2725-2026 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 30, 2024
Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
Packaging material was updated for the Bulb Irrigation Syringe (DYND20125), and additional testing done at Medline Corporate indicated the potential for the sterile barrier to be breached during transportation. This only affects two lot numbers (96922110001 and 96923100001).
Z-1157-2024 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedFeb 16, 2024
Dover" IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-1049-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedFeb 10, 2023
Surgical convenience kits labeled as:
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
Z-1126-2023 · View FDA record ↗ - Customed, IncTerminatedApr 14, 2016
Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1400-2016 · View FDA record ↗ - C.R. Bard, Inc.TerminatedFeb 16, 2016
REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units.
Report by a customer of an open package seal.
Z-0812-2016 · View FDA record ↗ - Customed, IncTerminatedSep 3, 2015
IRRIGATION TRAY W/BULB SYRINGE CUSTOMED 50/CS
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2551-2015 · View FDA record ↗ - Medtronic NeurosurgeryTerminatedJul 25, 2013
Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preim
Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expiration dates that were incorrect. The date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components in the kit.
Z-1810-2013 · View FDA record ↗ - Haemacure CorporationTerminatedMay 11, 2012
HemaSyst, Dual Cannula Tip with Adapter 16 ga. x 4" (10.2 cm). Product is labeled in part:"***Pouch label***HAEMACURE***HemaSyst***tm***Contents: One ***DUAL C
This product has been recalled due to the lot number being different on the box and pouch. The lot number on the box label was incorrectly printed as 11144 instead of 111144. The pouch label referenced the correct lot number, 111144.
Z-1537-2012 · View FDA record ↗ - Customed, IncTerminatedMar 21, 2012
Irrigation Tray w/Bulb syringe, catalog# 900-020
The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition.
Z-1252-2012 · View FDA record ↗
Registered firms
392 firms currently registered for this product code
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Bauer Und Haselbarth-chirurg Gmbh
ELLERAU Schleswig-Holstein, DE
Boston Scientific Corporation
SPENCER, IN, US
Biomet, Inc.
WARSAW, IN, US
Tai-shiny Technology Co., Ltd.
Guishan District Taoyuan, TW
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Tomy International, Inc.
Canton, MA, US
Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.
Shuyang Jiangsu, CN
Henan Aile Industrial Co., Ltd.
zhengzhou Henan, CN
Surgin Surgical Instrumentation, Inc.
Scottsdale, AZ, US
Suzhou Acmed Import & Export Co., Ltd.
SUZHOU Jiangsu, CN
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Gfa Production Xiamen Co., Ltd.
Tong An, Xiamen Fujian, CN
Richard Wolf Medical Instruments Corp.
VERNON HILLS, IL, US
Zhejiang Aicor Medical Technology Co., Ltd.
Linhai Zhejiang, CN
Isomedix Operations Inc.
Northborough, MA, US
Technimen Skillers
SIALKOT Punjab, PK
Cook Incorporated
Bloomington, IN, US
Fesun Shanghai Co., Ltd.
shanghai, CN
Medmolds
karachi Sindh, PK
Geodis Logistics
Clayton, IN, US
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Purebrand Slutions Ltd
London England, GB
Dms Holdings, Inc.,
Waukegan, IL, US
B. Braun Melsungen Ag
MELSUNGEN Hesse, DE
510(k) clearances
41 clearances for this product code
- Safkan, Inc.Nov 5, 2020
K201877 · OtoSet- Ear Cleaning System
- Micromedics, Inc.Mar 15, 2011
K102563 · SINGLE CANNULA EXTENDED APPLICATOR
- Shippert Medical Technologies Corp.Aug 17, 2009
K092022 · TISSU TRANS HARVEST TUBING
- Shippert Medical Technologies Corp.Jul 13, 2005
K050797 · TISSU-TRANS
- Sub-Q, Inc.Aug 23, 1999
K991254 · QS DELIVERY SYSTEM
- Sub-Q, Inc.Nov 6, 1998
K982435 · IRRIGATION SYRINGE KIT
- Zerowet, Inc.Jan 29, 1998
K974288 · ZEROWET SPLASHIELD
- Research Medical, Inc.Feb 19, 1997
K964833 · RMI DUAL FLUID IRRIGATING SYRINGE