Olympus Corporation of the Americas recalls Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog…
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause…
Read the official notice →- Date
- 2026-03-11
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Canada, Mexico,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-04-01
USOlympus 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.
- 2026-03-11
- US
Olympus Corporation of the Americas recalls Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System -…
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards…
FDA · DeviceOlympus Corporation of the AmericasInternational distribution in the country of Canada, Germany, Singapore,…Official notice → - US
Olympus Corporation of the Americas recalls Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be…
Potential for rubber fragment detachment during use.
- 2026-03-04
- US
Olympus Corporation of the Americas recalls Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
- US
Olympus Corporation of the Americas recalls Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
- 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 →
Other drugs & medical recalls in the United States
- 2026-03-11
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
B Braun Medical Inc recalls Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device…
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
FDA · DeviceB Braun Medical IncWorldwide - US Nationwide distribution in the state of TX and the country of…Official notice → - US
Staar Surgical AG recalls EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may…
FDA · DeviceStaar Surgical AGInternational distribution to the countries of India, Iran, Korea, Saudi Arabia.Official notice → - US
Roche Diagnostics Operations, Inc. recalls cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001…
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative,…
- US
GE Healthcare recalls GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image…
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on…
FDA · DeviceGE HealthcareWorldwide distribution - US Nationwide and the countries of Belarus, Brazil,…Official notice → - US
Abiomed, Inc. recalls Impella RP Flex with SmartAssist. Product Code: 1000323.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
FDA · DeviceAbiomed, Inc.Worldwide distribution - US Nationwide and the countries of Austria, Canada,…Official notice →