SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
Read the official notice →- Date
- 2026-02-18
- Country
- United States
- Brand
- SUREPULSE MEDICAL LTD
- Product
- Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
- Classification
- Class III
- Units
- Worldwide - US Nationwide distribution in the states of CT, TX and the…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2026-02-25
USWilson-Cook Medical Inc. recalls Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model…
Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
FDA · DeviceWilson-Cook Medical Inc.U.S. Distribution to states of: CA, CO, IN, and NC.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.
- 2026-02-18
- US
Steris Corporation recalls Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
FDA · DeviceSteris CorporationUS Nationwide distribution in the states of FL, NC, NY, OH, TN, TX, and VA.Official notice → - US
Intuitive Surgical, Inc. recalls da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both…
FDA · DeviceIntuitive Surgical, Inc.US Nationwide distribution in the states of KS, AZ, MA, FL, MI, NC, IL, DC,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.X,…
Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - US
Alphatec Spine, Inc. recalls ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC…
Due a design issue where the navigated array connection geometry is incorrect.
FDA · DeviceAlphatec Spine, Inc.U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO,…Official notice →