Olympus Corporation of the Americas recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Potential for detachment of a distal tip component of the device during use.
Read the official notice →- Date
- 2026-04-29
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
- Classification
- Class II
- Units
- International distribution in the countries of Australia, Japan, Hong Kong,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-07-15
USOlympus 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 → - 2026-04-08
- US
Olympus Corporation of the Americas recalls Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS…
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning…
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, Chile,…Official notice → - 2026-04-01
- US
Olympus Corporation of the Americas recalls Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting Forceps Model/Catalog Number: 3005PK Product…
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
FDA · DeviceOlympus Corporation of the AmericasWorldwide - US Nationwide and the countries of Canada, Mexico, EU, Australia,…Official notice → - US
Olympus Corporation of the Americas recalls Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Other drugs & medical recalls in the United States
- 2026-04-29
- US
Magellan Diagnostics, Inc. recalls LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: "…
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results…
FDA · DeviceMagellan Diagnostics, Inc.Worldwide - US Nationwide and the countries of Argentina, Australia, Bhutan,…Official notice → - US
Medline Industries, LP recalls Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes GU DAVINCI PACK - LF DYNJ909398A ROBOTIC PACK…
Unapproved design changes to the products outside of the 510(k) clearance.
FDA · DeviceMedline Industries, LPWorldwide distribution - US Nationwide and the countries of Canada, Panama,…Official notice → - US
Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 65CM 038 NB 0SH; Catalog No.: 10714014; Product/UPN No.: H787107140145…
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
FDA · DeviceAngiodynamics, Inc.Worldwide distribution - US Nationwide and the countries of Austria,…Official notice → - US
Medline Industries, LP recalls Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
- US
Integra LifeSciences Corp. (NeuroSciences) recalls CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Software issue that renders the touch screen unresponsive.
FDA · DeviceIntegra LifeSciences Corp. (NeuroSciences)Worldwide - US Nationwide distribution in the states of MI & NY. The countries…Official notice → - US
Uvlizer c/o RAIS INTERNATIONAL LLC recalls The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED lights. The…
In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international safety guidelines for skin and eye exposure.