Olympus Corporation of the Americas recalls Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog…
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Read the official notice →- Date
- 2026-02-11
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L…
- Classification
- Class II
- Units
- US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-02-25
US
Olympus Corporation of the Americas recalls Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Brazil, Canada,…Official notice →US
Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic…
Issue with software algorithm which may lead to overpressure events.
- 2026-02-11
US
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments…
Devices which did not undergo thermoforming could deform and lose performance.
FDA · DeviceOlympus Corporation of the AmericasWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →- 2025-12-03
US
Olympus Corporation of the Americas recalls Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product…
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these…
US
Olympus Corporation of the Americas recalls Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an…
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
- 2025-11-26
US
Olympus Corporation of the Americas recalls Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy…
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were…
FDA · DeviceOlympus Corporation of the AmericasUS Domestic: AK, CA, IA, KY, WA, WI; OUS International: Canada and Germany.Official notice →
Other drugs & medical recalls in the United States
- 2026-02-11
US
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay…
FDA · DeviceEncore Medical, LPUS: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CAOfficial notice →US
Intuitive Surgical, Inc. recalls Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200;…
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion…
FDA · DeviceIntuitive Surgical, Inc.U.S.: AL, AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MD, MI, MN, MS, MO, NC, NJ,…Official notice →US
VANTIVE US HEALTHCARE LLC recalls PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
US
Beckman Coulter, Inc. recalls COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a…
Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.
FDA · DeviceBeckman Coulter, Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice →US
Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new…
FDA · DeviceBoston Scientific CorporationWorldwide distribution. US Nationwide including Puerto Rico; Algeria,…Official notice →US
SUN PHARMACEUTICAL INDUSTRIES INC recalls Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T…
Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.