September 17, 2025Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Hazard: Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.
September 17, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 /
Hazard: Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
September 17, 2025Medical DevicesFDA
Quest International, Inc. recalls Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 0
Hazard: Measles IgM Test Kit lacks premarket approval or clearance.
September 17, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000
Hazard: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
September 17, 2025Medical DevicesFDA
Boston Scientific Corporation recalls ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-0
Hazard: Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
September 17, 2025Medical DevicesFDA
Encore Medical, LP recalls Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version
Hazard: Their is a potential that the reamer may kick or bind up during or immediately prior to use.
September 17, 2025Medical DevicesFDA
Encore Medical, LP recalls Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310
Hazard: Their is a potential that the reamer may kick or bind up during or immediately prior to use.
September 17, 2025Medical DevicesFDA
Encore Medical, LP recalls Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 8
Hazard: Their is a potential that the reamer may kick or bind up during or immediately prior to use.
September 17, 2025Medical DevicesFDA
Encore Medical, LP recalls Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Pr
Hazard: Their is a potential that the reamer may kick or bind up during or immediately prior to use.
September 17, 2025Medical DevicesFDA
Quidel Corporation recalls QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Hazard: Dipstick strep A test has potential for false positive results.
September 17, 2025Medical DevicesFDA
NOXBOX LTD recalls NOxBOXi Nitric Oxide Delivery System
Hazard: Replacement of the internal Sample Pump due to high failure rates.
September 17, 2025Medical DevicesFDA
Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular, Software 8.0.0.4.
Hazard: Software issue that results in the display of outdated information.
September 17, 2025Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Hazard: Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
September 17, 2025Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/
Hazard: Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
September 17, 2025Medical DevicesFDA
CORNEAT VISION, LTD. recalls CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX o
Hazard: Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
September 17, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4.
Hazard: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
September 17, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Hazard: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
September 17, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventio
Hazard: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
September 17, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M00671
Hazard: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
September 17, 2025Medical DevicesFDA
Contract Medical International GmbH recalls Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 38
Hazard: Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.
September 17, 2025Medical DevicesFDA
AVID Medical, Inc. recalls Halyard, CPT BASIC IR PACK. Model Number: 1646381. Convenience kit.
Hazard: Potential for open header bag seals, compromising sterility.
September 17, 2025Medical DevicesFDA
AVID Medical, Inc. recalls Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Hazard: Potential for open header bag seals, compromising sterility.
September 17, 2025Medical DevicesFDA
Siemens Medical Solutions USA, Inc recalls Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
Hazard: Limited system movements after startup .
September 17, 2025Medical DevicesFDA
B.Braun Medical S.A.S. recalls Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version
Hazard: The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
September 17, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device
Hazard: Potential for undetected, deformed a-traumatic tips.
September 17, 2025Medical DevicesFDA
WASATCH PHOTONICS recalls Wasatch Photonics 785/830-SR and 785-ER-ILC Raman Spectrometers, Product Models: 785-SR-ILP, 785-SR-ILC, 830-SR-ILP,
Hazard: Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The failure modes have never been found to occur in these models, whether in the field or factory, but could potentially occur under excessive force or extreme, continuous vibration.
September 10, 2025Medical DevicesFDA
ICU Medical Inc. recalls Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubin
Hazard: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
September 10, 2025Medical DevicesFDA
ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 10
Hazard: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
September 10, 2025Medical DevicesFDA
ICU Medical Inc. recalls Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 5
Hazard: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
September 10, 2025Medical DevicesFDA
ICU Medical Inc. recalls Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper incl
Hazard: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.