Evacuator, Gastro-urology
Gastroenterology, Urology · 21 CFR 876.4370
Recent MDR events
201 adverse event reports on file
- BARD® ELLIK EVACUATORMay 22, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-03361
- BARD® ELLIK EVACUATORMar 10, 2026MalfunctionC.r. Bard Inc. (covington) -10182331018233-2026-01629
- IRRIGATIONFeb 23, 2026MalfunctionBoston Scientific Corporation2124215-2026-09906
- UROVAC BLADDER EVACUATORNov 21, 2025MalfunctionBoston Scientific Corporation2124215-2025-85106
- BARD® ELLIK EVACUATOROct 16, 2025MalfunctionC.r. Bard Inc. (covington) -10182331018233-2025-09226
- IRRIGATIONSep 17, 2025MalfunctionBoston Scientific Corporation2124215-2025-64993
- AHTOAug 21, 2025MalfunctionStryker Corporation22860363
- AHTOAug 20, 2025MalfunctionStryker Corporation22849245
- BARD® ELLIK EVACUATORJul 23, 2025MalfunctionC.r. Bard Inc. (covington) -10182331018233-2025-06043
- BARD® ELLIK EVACUATORJul 17, 2025MalfunctionC.r. Bard Inc. (covington) -10182331018233-2025-05952
Event type breakdown
Recalls
12 recall events for this product code
- Olympus Corporation of the AmericasOpen, ClassifiedJul 10, 2026
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Z-2718-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedJul 10, 2026
Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Z-2719-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedJul 10, 2026
Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Z-2720-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedJul 10, 2026
Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
Z-2721-2026 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedJul 21, 2025
Glass Body For 194 Ellik Evacuator. Model Number: 190A.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2141-2025 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedJul 21, 2025
Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2142-2025 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedJul 21, 2025
Ellik Evacuator. Model Number: 194.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2143-2025 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedJul 21, 2025
Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2144-2025 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedJul 21, 2025
Ellik Evacuator Adapter, Locking. Model Number: 190-NRS.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2145-2025 · View FDA record ↗ - Olympus Corporation of the AmericasOpen, ClassifiedJul 21, 2025
Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Z-2146-2025 · View FDA record ↗
Registered firms
62 firms currently registered for this product code
Integra Biotechnical, Sa De Cv
Tijuana Baja California, MX
Tekno Medical Optik-chirurgie Gmbh
TUTTLINGEN-Nendingen Baden-Wurttemberg, DE
Sterigenics U.s. Llc
Hayward, CA, US
Endonest Medical Systems Llp
PALGHAR Maharashtra, IN
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
C.r. Bard, Inc.
MADISON, GA, US
Stryker Emea Supply Chain Services
Venlo Limburg, NL
Sterlab
SIGNES Var, FR
E.m.s. Electro Medical Systems S.a.
NYON Vaud, CH
Isomedix Operations Inc
GROVEPORT, OH, US
Sterigenics Us Llc
Fort Worth, TX, US
Gri Medical Products, Inc.
CAVE CREEK, AZ, US
Sklar Corporation - Warehouse
Salisbury, MD, US
Karl Storz Endoscopy-america, Inc.
Auburn, MA, US
Boston Scientific Corporation
Saint Paul, MN, US
Boston Scientific Corporation
Marlborough, MA, US
Sterigenics Us Llc
Gurnee, IL, US
Baxter Healthcare Of Puerto Rico Llc
AIBONITO, PR, US
Isomedix Operations, Inc.
Libertyville, IL, US
E.m.s. Electro Medical Systems S.a.
NYON Vaud, CH
The Metrix Company
DUBUQUE, IA, US
Karl Storz Se & Co Kg
TUTTLINGEN Baden-Wurttemberg, DE
Karl Storz Se & Co. Kg
TUTTLINGEN Baden-Wurttemberg, DE
Karl Storz Endoscopy-america, Inc.
El Segundo, CA, US
Boston Scientific Corporation
Coventry, RI, US
510(k) clearances
14 clearances for this product code
- Electro Medical Systems SADec 16, 1996
K964111 · LITHOVAC SUCTION/ASPIRATION PROBE
- Northgate Technologies, Inc.Oct 28, 1992
K921451 · EVACUATOR, GASTRO-UROLOGY
- Northgate Technologies, Inc.Oct 28, 1992
K921088 · EVACUATOR, GASTRO-UROLOGY
- Mitron Technologies, Inc.Apr 1, 1991
K910728 · CLEANFLOW SYSTEM
- Van-Tec, Inc.Mar 2, 1988
K880099 · VAN-TEC BLADDER EVACUATOR
- Bel-Can IndustriesFeb 5, 1988
K874493 · BELLA - VAC IRRIGATOR
- R. J. Ltd., Ind.Mar 5, 1986
K860266 · ELLIK EVACUATOR
- American Hospital Supply Corp.May 25, 1983
K830546 · DOSIMETRIC RELEASE