April 2, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F;
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
April 2, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack
Hazard: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
April 2, 2025Medical DevicesFDA
Merit Medical Systems, Inc. recalls Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Hazard: Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
April 2, 2025Medical DevicesFDA
Zimmer, Inc. recalls NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number
Hazard: The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.
April 2, 2025Medical DevicesFDA
Orthofix U.S. LLC recalls Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy:
Hazard: The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.
April 2, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468; 2) MTS,RIGHT HEART,KIT,W/TRA
Hazard: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
April 2, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG; medical convenience kit, REF 600605710
Hazard: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
April 2, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
Hazard: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
April 2, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 80641722; medical convenience kit
Hazard: The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
April 2, 2025Medical DevicesFDA
St. Jude Medical recalls CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web
Hazard: Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some patient profile information being duplicated while other patient information is missing.
April 2, 2025Medical DevicesFDA
American Contract Systems, Inc. recalls Brand Name: Banner University Med Ctr. Product Name: Cardiac Cath Lab Pack-170278 Model/Catalog Number: GSCC40G Sof
Hazard: Sterility assurance with procedure trays
April 2, 2025Medical DevicesFDA
American Contract Systems, Inc. recalls Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A
Hazard: Sterility assurance with procedure trays
April 2, 2025Medical DevicesFDA
American Contract Systems, Inc. recalls Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Conveni
Hazard: Sterility assurance with procedure trays
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS
Hazard: Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter TruSystem 7500, Product Code 4091000
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Floor mounting column TS 7500 U, Product Code 1730732
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Stationary column TruSystem 7500 U, Product Code 1730731
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Mobile column TruSystem 7500 U, Product Code 1730720
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Mobile column TruSystem 7500, Product Code 1717023
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Floor mounting column TruSystem 7500, Product Code 1717021
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Stationary column TruSystem 7500, Product Code 1717020
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Operating table column TS7500 MOBIUS, Product Code 1704695
Hazard: There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled.
April 2, 2025Medical DevicesFDA
Premier Dental Products Co recalls Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Hazard: The hardness not meeting the material specification and may cause the diamond bur to bend.
April 2, 2025Medical DevicesFDA
Calyxo, Inc. recalls CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urina
Hazard: Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions, for patients with high viscosity fluid in the kidney, not to continue providing fluid inflow in the presence of unresolved slow or absent fluid outflow because this can create intrarenal pressure imbalance, and lead to excessive intrarenal pressure.