Recall archive
110 recalls · page 2 of 5
Reported Dec 25, 2024
Duravent Silicone Ventilation Tube. Model Number: 240075.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the…
FDA (openFDA device enforcement)
Reported Dec 11, 2024
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Reason for recall — High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a…
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human…
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A Software Version: N/A Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details · Reason for recall — Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 6, 2024
Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details · Reason for recall — During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2024
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply…
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 14, 2024
Soltive Premium SuperPulsed Laser System, Model TFL-PLS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 31, 2024
ESG-410 Electrosurgical Generator- In conjunction with electrosurgical accessories intended for cutting and coagulation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery
FDA (openFDA device enforcement)
Reported Jul 10, 2024
EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The EasySuite 4K system includes a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to…
FDA (openFDA device enforcement)
Reported Jun 12, 2024
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the…
FDA (openFDA device enforcement)
Reported May 29, 2024
InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Potential for distal end of the sheath to break off during a procedure.
FDA (openFDA device enforcement)
Reported May 8, 2024
POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 17, 2024
Hemostasis Probe, Model: CD-B622LA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — The BICOAG Hemostasis Probe with a coaxial plug was mispackaged into the package and labeled as a BICOAG Hemostasis Probe with a fixed pin connector.
FDA (openFDA device enforcement)
Reported Apr 3, 2024
InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off.…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 6, 2024
Colonoscope, Model Number CF-H180AL.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
ESG PK CUTTING FORCEPS, 5MM, 33CM
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
FDA (openFDA device enforcement)
Reported Feb 21, 2024
Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product details — Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage,…
FDA (openFDA device enforcement)
Reported Feb 14, 2024
Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 7, 2024
EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in…
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 24, 2024
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Reason for recall — The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 17, 2024
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes.
FDA (openFDA device enforcement)
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