Olympus Corporation of the Americas recalls 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.
Read the official notice →- Date
- 2026-07-22
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Olympus Corporation of the Americas recalls
- 2026-09-02
USOlympus Corporation of the Americas recalls POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting &…
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
FDA · DeviceOlympus Corporation of the AmericasWorldwide - US Nationwide distribution in the states of Kansas and Florida.…Official notice →- 2026-07-29
- US
Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Olympus Corporation of the Americas recalls Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying…
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
FDA · DeviceOlympus Corporation of the AmericasWorldwide - US Nationwide distribution in the states of OH, CA, NJ, FL and the…Official notice → - 2026-07-15
- US
Olympus Corporation of the Americas recalls Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to…
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
- 2026-04-29
- US
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
XXX
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, China,…Official notice → - US
Olympus Corporation of the Americas recalls OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2113.
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, China,…Official notice →
Other drugs & medical recalls in the United States
- 2026-07-22
- US
Boston Scientific Corporation recalls 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…
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution. OUS consignee list pending.Official notice → - US
ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
FDA · DeviceICU Medical, Inc.Worldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Intuitive Surgical, Inc. recalls da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result…
FDA · DeviceIntuitive Surgical, Inc.Worldwide - US Nationwide distribution in the states of NJ, OR, NY, FL, AL,…Official notice → - US
Argon Medical Devices, Inc recalls General Biospy Tray, REF: GUTS1000
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
FDA · DeviceArgon Medical Devices, IncDistribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.Official notice → - US
Abiomed, Inc. recalls ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart…
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr…
FDA · DeviceAbiomed, Inc.Worldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium…Official notice → - US
Oscor Inc. recalls Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart…
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.