Olympus Corporation of the Americas recalls Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product…
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 addition, the body of the transducer handpiece may gradually increase in…
Read the official notice →- Date
- 2025-11-19
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Canada, India,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-12-03
USOlympus 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 → - 2025-11-19
- US
Olympus Corporation of the Americas recalls Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical…
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of GU, and MP.Official notice → - 2025-10-22
- US
Olympus Corporation of the Americas recalls EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
- 2025-09-17
- US
Olympus Corporation of the Americas recalls ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made…
Potential for undetected, deformed a-traumatic tips.
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2025-08-27
- US
Olympus Corporation of the Americas recalls Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP).…
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
Other drugs & medical recalls in the United States
- 2025-11-19
- US
Sonesta Medical AB recalls Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 -…
Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.
- US
Abbott Medical recalls Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 .…
- US
GE Healthcare Finland Oy recalls B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-004 6160000-005 6160000-101 6160000-102…
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of…
- US
Medline Industries, LP recalls Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic…
FDA · DeviceMedline Industries, LPInternational distribution to Mexico and Panama. US nationwide distribution to…Official notice → - US
Cerenovus Inc recalls CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4…
Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
FDA · DeviceCerenovus IncUS Nationwide distribution: CO, GA, MD, UT, OK, WI, MA, TN, SC, TX, CA, WV,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls MAGNETOM Cima.X Upgrade. Model Number: 11689304.
There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting…
FDA · DeviceSiemens Medical Solutions USA, IncUS distribution to California. International distribution to Australia,…Official notice →