Recall archive
112 recalls · page 1 of 5
Reported Oct 7, 2026Updated Oct 13, 2026
Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 30, 2026Updated Oct 6, 2026
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 2, 2026Updated Sep 7, 2026
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting &…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
FDA (openFDA device enforcement)
Reported Jul 29, 2026
Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 22, 2026
Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2026
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V-…
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 has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
FDA (openFDA device enforcement)
Reported Apr 29, 2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Potential for detachment of a distal tip component of the device during use.
15 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 8, 2026
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS…
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 — Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 1, 2026
Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
10 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 11, 2026
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer.…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 4, 2026
Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the…
20 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 25, 2026
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Issue with software algorithm which may lead to overpressure events.
14 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 11, 2026
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
31 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 26, 2025
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract…
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma…
22 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 17, 2025
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
Matched: Brand — Potential for undetected, deformed a-traumatic tips.
FDA (openFDA device enforcement)
Reported Aug 27, 2025
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 30, 2025
Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product…
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 11, 2025
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual…
FDA (openFDA device enforcement)
Reported May 7, 2025
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Olympus Corporation of the Americas
Matched: Brand — Preset treatment parameters are not consistently being used in accordance with the IFU.
FDA (openFDA device enforcement)
Reported Feb 19, 2025
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Olympus Corporation of the Americas
Matched: Brand · Product · Product details — Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
FDA (openFDA device enforcement)
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