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.
Read the official notice →- Date
- 2026-03-11
- Country
- United States
- Brand
- Olympus Corporation of the Americas
- Product
- Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-04-01
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.
- 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 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…
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of Canada, Mexico,…Official notice →- 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.
Other drugs & medical recalls in the United States
- 2026-03-11
US
Vascutek, Ltd. recalls Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE,…
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of…
FDA · DeviceVascutek, Ltd.US Nationwide distribution including in the states of FL, PA, TX, NC, NY, CA,…Official notice →US
Diagnostica Stago, Inc. recalls Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description:…
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
FDA · DeviceDiagnostica Stago, Inc.Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA,…Official notice →US
ESAOTE S.P.A. recalls Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.
US
Datascope Corp. recalls CS300 IABP. Software Version CS300 IABP C.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
FDA · DeviceDatascope Corp.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice →US
Aesculap Inc recalls Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product…
There is the potential for the length of the trocar shaft to be too long.
FDA · DeviceAesculap IncUS Nationwide distribution in the states of AZ, AR, CA, CO, FL, GA, HI, IA,…Official notice →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 →