Class IIOngoingZ-2551-2025
Boston Scientific Corporation recalls Preventive Maintenance (PM) Kit ICEFX
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Boston Scientific Corp…MNSep 17, 2025
Recalls: Process control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 517–528 of 822 recalls
Class IIOngoingZ-2550-2025
Boston Scientific Corporation recalls ICEfx Cryoablation System
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
Boston Scientific Corp…MNSep 17, 2025
Class IIOngoingZ-2520-2025
O&M HALYARD INC recalls Orthopedic Pack
Surgical drape packs may have open seals, which may compromise the sterility of the product.
O&M HALYARD INCGASep 10, 2025
Class IIOngoingZ-2518-2025
Merge Healthcare, Inc. recalls Merge Hemo
Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client ( Pressure…
Merge Healthcare, Inc.WISep 10, 2025
Class IIOngoingZ-2515-2025
Bio-Rad Laboratories, Inc. recalls Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo I…
Due to a risk of false positive results that could lead to unnecessary medical treatment.
Bio-Rad Laboratories,…WASep 10, 2025
Class IIOngoingZ-2514-2025
Preat Corp recalls NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base
Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry;…
Preat CorpCASep 10, 2025
Class IIOngoingZ-2513-2025
Medshape, INC. recalls Medshape Universal Joints
Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
Medshape, INC.GASep 10, 2025
Class IIIOngoingZ-2451-2025
Bausch & Lomb Surgical, Inc. recalls Akreos
An off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acui…
Bausch & Lomb Surgical…FLSep 3, 2025
Class IIOngoingZ-2419-2025
THOR Photomedicine Ltd recalls Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186…
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
THOR Photomedicine LtdSep 3, 2025
Class IIOngoingZ-2418-2025
THOR Photomedicine Ltd recalls Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189…
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
THOR Photomedicine LtdSep 3, 2025
Class IIOngoingZ-2417-2025
THOR Photomedicine Ltd recalls Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Vers…
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
THOR Photomedicine LtdSep 3, 2025
Class IIOngoingZ-2416-2025
THOR Photomedicine Ltd recalls Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version…
The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift.
THOR Photomedicine LtdSep 3, 2025