Medical device recalls reported in 2023

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Reported	Recall	Class	Product	Firm
2023-10-11	Z-2652-2023	Class II	Venue Go Standard Carts Ref:	GE MEDICAL SYSTEMS, ISRAEL LTD.
2023-10-11	Z-2653-2023	Class II	Apellis Injection Kit 29g Injection Needle -single use intended to…	Apellis Pharmaceuticals, Inc.
2023-10-11	Z-2654-2023	Class II	EarlyVue VS30 Vitals Monitor	Philips North America Llc
2023-10-11	Z-2655-2023	Class II	EarlyVue VS30 Vital Signs Monitor	Philips North America Llc
2023-10-11	Z-2656-2023	Class II	F2-01 Frame	GE Medical Systems China Co., Ltd.
2023-10-11	Z-2657-2023	Class II	Restore Clinician Programmer Application Software	Medtronic Neuromodulation
2023-10-11	Z-2658-2023	Class II	Heartmate 3 LVAS Implant Kit	Thoratec Corp.
2023-10-11	Z-2659-2023	Class II	Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic…	Olympus Corporation of the Americas
2023-10-11	Z-2660-2023	Class II	Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180…	Olympus Corporation of the Americas
2023-10-11	Z-2661-2023	Class II	Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide…	Olympus Corporation of the Americas
2023-10-11	Z-2662-2023	Class II	Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450…	Olympus Corporation of the Americas
2023-10-11	Z-2663-2023	Class II	Veran : Percutaneous Always on Track Models: INS-5040 Always-On…	Olympus Corporation of the Americas
2023-10-11	Z-2664-2023	Class II	Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga…	Olympus Corporation of the Americas
2023-10-11	Z-2665-2023	Class II	therascreen ¿KRAS RGQ PCR Kit	Qiagen GmbH
2023-10-11	Z-2666-2023	Class II	ADVIA Chemistry Iron_2	Siemens Healthcare Diagnostics, Inc.
2023-10-04	Z-2628-2023	Class II	Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to…	Ambu Inc.
2023-10-04	Z-2629-2023	Class II	Aquilex Fluid Control System-Intended to provide fluid distension of…	WOM World Of Medicine AG
2023-10-04	Z-2631-2023	Class I	Philips Respironics V60/V60 Plus Ventilator	Philips Respironics, Inc.
2023-10-04	Z-2632-2023	Class II	Palindrome Chronic Catheter Kit Symmetrical Tip14	Covidien LP
2023-10-04	Z-2633-2023	Class II	exoplan version 3	Exocad GmbH
2023-10-04	Z-2634-2023	Class II	Various Medical Products stored on pallets	Inmar Supply Chain Solutions, LLC
2023-10-04	Z-2635-2023	Class II	Ivenix Infusion System	Fresenius Kabi USA, LLC
2023-10-04	Z-2636-2023	Class II	ProSun International Luxura Vegaz	J&T Health and Wellness LLC
2023-10-04	Z-2637-2023	Class II	3M Attest Super Rapid Readout Biological Indicator	3M Company - Health Care Business
2023-10-04	Z-2638-2023	Class II	3M Attest Super Rapid Readout Steam Challenge Pack	3M Company - Health Care Business
2023-10-04	Z-2639-2023	Class II	3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack	3M Company - Health Care Business
2023-10-04	Z-2640-2023	Class II	3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack	3M Company - Health Care Business
2023-10-04	Z-2641-2023	Class II	MobileLink Acetabular Cup System	Waldemar Link GmbH & Co. KG (Mfg Site)
2023-10-04	Z-2642-2023	Class II	Henke-Ject-2 part luer sterile single use syringes	Wolf, Henke Sass, Gmbh
2023-10-04	Z-2643-2023	Class II	B	B. Braun Medical, Inc.
2023-10-04	Z-2644-2023	Class II	B	B. Braun Medical, Inc.
2023-10-04	Z-2645-2023	Class II	Cinchlock SS Knotless Anchor Inserter	Stryker Corporation
2023-10-04	Z-2646-2023	Class II	BD Pyxis MedBank MedPass Software	CareFusion 303, Inc.
2023-10-04	Z-2647-2023	Class II	Baxter Epiphany Cardio Server E3 ECG Management System Servers with…	Baxter Healthcare Corporation
2023-09-27	Z-2525-2023	Class I	Hamilton-C1	Hamilton Medical, Inc.
2023-09-27	Z-2526-2023	Class I	Hamilton-T1	Hamilton Medical, Inc.
2023-09-27	Z-2527-2023	Class I	Hamilton-T1	Hamilton Medical, Inc.
2023-09-27	Z-2528-2023	Class I	Hamilton-MR1	Hamilton Medical, Inc.
2023-09-27	Z-2529-2023	Class I	Hamilton C1/T1/MR1	Hamilton Medical, Inc.
2023-09-27	Z-2530-2023	Class I	Hamilton-T1	Hamilton Medical, Inc.
2023-09-27	Z-2589-2023	Class II	Five S 5 3x65	Karl Storz Endoscopy
2023-09-27	Z-2590-2023	Class II	Arrow ErgoPack Pressure Injectable One-Lumen PICC	ARROW INTERNATIONAL Inc.
2023-09-27	Z-2591-2023	Class II	Arrow ErgoPack	ARROW INTERNATIONAL Inc.
2023-09-27	Z-2592-2023	Class II	Membrane Changer Single-Use	SenTec AG
2023-09-27	Z-2593-2023	Class II	APK2 Pressure-Sensing Wheelchair Cushions	Aquila Corporation
2023-09-27	Z-2594-2023	Class II	SofTech Pressure-Sensing Wheelchair Cushions	Aquila Corporation
2023-09-27	Z-2595-2023	Class II	MEDLINE STERILE IRIS SCISSORS CVD/STD	MEDLINE INDUSTRIES, LP - Northfield
2023-09-27	Z-2596-2023	Class II	Stryker ACM	Stryker Corporation
2023-09-27	Z-2597-2023	Class II	Stryker ACM	Stryker Corporation
2023-09-27	Z-2598-2023	Class II	Stryker ACM	Stryker Corporation
2023-09-27	Z-2599-2023	Class II	Stryker ACM	Stryker Corporation
2023-09-27	Z-2600-2023	Class II	Stryker ACM	Stryker Corporation
2023-09-27	Z-2601-2023	Class II	Stryker ACM	Stryker Corporation
2023-09-27	Z-2602-2023	Class II	Stryker ACM	Stryker Corporation
2023-09-27	Z-2603-2023	Class II	DJO Surgical: Empowr Knee	Encore Medical, LP
2023-09-27	Z-2604-2023	Class II	DJO Surgical: Delta Ceramic Femoral Head	Encore Medical, LP
2023-09-27	Z-2605-2023	Class II	DJO Surgical: CLP Hip	Encore Medical, LP
2023-09-27	Z-2606-2023	Class II	DJO Surgical: Reverse Shoulder System	Encore Medical, LP
2023-09-27	Z-2607-2023	Class II	DJO Surgical: Altivate Reverse	Encore Medical, LP
2023-09-27	Z-2608-2023	Class II	Patient Information Center iX with Software Version Number 4	Philips North America Llc
2023-09-27	Z-2609-2023	Class II	Liquid Assayed Chemistry Control Premium Plus Level 3	Randox Laboratories Ltd.
2023-09-27	Z-2610-2023	Class II	TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3	Tytek Medical Inc
2023-09-27	Z-2611-2023	Class II	TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge	Tytek Medical Inc
2023-09-27	Z-2612-2023	Class II	TyTek PneumoDart- Intended for introduction into the body to…	Tytek Medical Inc
2023-09-27	Z-2613-2023	Class II	Prucka 3 Amplifiers	GE Medical Systems Information Technologies Inc
2023-09-27	Z-2614-2023	Class II	Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF…	Abbott Medical
2023-09-27	Z-2615-2023	Class II	Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D…	Abbott Medical
2023-09-27	Z-2616-2023	Class II	PDS Plus Antibacterial	ETHICON, LLC
2023-09-27	Z-2617-2023	Class II	PDS II	ETHICON, LLC
2023-09-27	Z-2618-2023	Class II	Omnipod 5 Automated Insulin Delivery System	Insulet Corporation
2023-09-27	Z-2619-2023	Class II	MINISCAV	R A Medical Services
2023-09-27	Z-2620-2023	Class II	COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped…	Copan Diagnostics Inc
2023-09-27	Z-2621-2023	Class II	smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL…	Smith & Nephew Inc
2023-09-27	Z-2622-2023	Class II	COOLIEF RF Generator is an 80-watt Radio-Frequency	Avanos Medical, Inc.
2023-09-27	Z-2623-2023	Class II	VITROS XT Chemistry Products TBIL-ALKP Slides	Ortho-Clinical Diagnostics, INc.
2023-09-27	Z-2624-2023	Class II	VITROS XT Chemistry Products ALKP Slides	Ortho-Clinical Diagnostics, INc.
2023-09-27	Z-2625-2023	Class II	Philips Tempus Pro Patient Monitor	Remote Diagnostic Technologies Ltd.
2023-09-27	Z-2626-2023	Class II	FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask…	O&M HALYARD, INC.
2023-09-27	Z-2627-2023	Class II	Perifix¿ / Epidural anesthesia set	B. Braun Medical, Inc.
2023-09-20	Z-2450-2023	Class I	Mallinckrodt One-Way Valve	Mallinckrodt Manufacturing LLC
2023-09-20	Z-2505-2023	Class I	Proclaim XR 5 Implantable Pulse Genterator REF 3660	Abbott Medical
2023-09-20	Z-2506-2023	Class I	Proclaim" XR 7 Implantable Pulse Generator REF 3662	Abbott Medical
2023-09-20	Z-2507-2023	Class I	Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product…	Abbott Medical
2023-09-20	Z-2508-2023	Class I	Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product…	Abbott Medical
2023-09-20	Z-2509-2023	Class I	Proclaim DRG Implantable Pulse Generator REF 3664 Product…	Abbott Medical
2023-09-20	Z-2510-2023	Class I	Infinity 5 Implantable Pulse Generator REF 6660 Product Description:…	Abbott Medical
2023-09-20	Z-2511-2023	Class I	Infinity 7 Implantable Pulse Generator REF 6662 Product Description:…	Abbott Medical
2023-09-20	Z-2514-2023	Class I	HUDSON RCI Addipak	MEDLINE INDUSTRIES, LP - Northfield
2023-09-20	Z-2524-2023	Class II	Magnifuse Bone Graft	Medtronic Sofamor Danek USA Inc
2023-09-20	Z-2531-2023	Class II	remel TODD HEWITT W	Remel, Inc
2023-09-20	Z-2532-2023	Class II	ASG-001	Advance Medical Designs, Inc.
2023-09-20	Z-2533-2023	Class II	50-GEL20	Advance Medical Designs, Inc.
2023-09-20	Z-2534-2023	Class II	Procedural kits containing ultrasonic transmission gel	Advance Medical Designs, Inc.
2023-09-20	Z-2535-2023	Class II	Procedural kits containing ultrasonic transmission gel	Advance Medical Designs, Inc.
2023-09-20	Z-2536-2023	Class II	Procedural kits containing ultrasonic transmission gel	Advance Medical Designs, Inc.
2023-09-20	Z-2537-2023	Class II	procedural kits containing ultrasonic transmission gel	Advance Medical Designs, Inc.
2023-09-20	Z-2538-2023	Class II	nanoDot D2DNS	Landauer
2023-09-20	Z-2539-2023	Class II	nanoDot D2DNS	Landauer
2023-09-20	Z-2540-2023	Class II	nanoDot D2DNN	Landauer
2023-09-20	Z-2541-2023	Class II	nanoDot D2DNN	Landauer
2023-09-20	Z-2542-2023	Class II	nanoDot D2DNS	Landauer
2023-09-20	Z-2543-2023	Class II	nanoDot D2DNS	Landauer
2023-09-20	Z-2544-2023	Class II	nanoDot D2DNS	Landauer
2023-09-20	Z-2545-2023	Class II	nanoDot D2DXN	Landauer
2023-09-20	Z-2546-2023	Class II	nanoDot D2DXN	Landauer
2023-09-20	Z-2547-2023	Class II	nanoDot D2DXS	Landauer
2023-09-20	Z-2548-2023	Class II	nanoDot D2DXS	Landauer
2023-09-20	Z-2549-2023	Class II	Calibrate	Landauer
2023-09-20	Z-2550-2023	Class II	Calibrate	Landauer
2023-09-20	Z-2551-2023	Class II	QC	Landauer
2023-09-20	Z-2552-2023	Class II	QC	Landauer
2023-09-20	Z-2553-2023	Class II	nanoDot kit	Landauer
2023-09-20	Z-2554-2023	Class II	nanoDot A	Landauer
2023-09-20	Z-2555-2023	Class II	nanoDot B	Landauer
2023-09-20	Z-2556-2023	Class II	nanoDot C	Landauer
2023-09-20	Z-2557-2023	Class II	Calibrate	Landauer
2023-09-20	Z-2558-2023	Class II	QC	Landauer
2023-09-20	Z-2559-2023	Class II	Calibrate	Landauer
2023-09-20	Z-2560-2023	Class II	QC	Landauer
2023-09-20	Z-2561-2023	Class II	nanoDot D2DNN	Landauer
2023-09-20	Z-2562-2023	Class II	nanoDot D2DNS	Landauer
2023-09-20	Z-2563-2023	Class II	nanoDot D2DNN	Landauer
2023-09-20	Z-2564-2023	Class II	Calibrate	Landauer
2023-09-20	Z-2565-2023	Class II	Calibrate	Landauer
2023-09-20	Z-2566-2023	Class II	Calibrate	Landauer
2023-09-20	Z-2567-2023	Class II	QC	Landauer
2023-09-20	Z-2568-2023	Class II	QC	Landauer
2023-09-20	Z-2569-2023	Class II	QC	Landauer
2023-09-20	Z-2570-2023	Class II	Calibrate	Landauer
2023-09-20	Z-2571-2023	Class II	Constancy	Landauer
2023-09-20	Z-2572-2023	Class II	Constancy	Landauer
2023-09-20	Z-2573-2023	Class II	NanoDots	Landauer
2023-09-20	Z-2574-2023	Class II	NanoDots	Landauer
2023-09-20	Z-2575-2023	Class II	Reader	Landauer
2023-09-20	Z-2576-2023	Class III	KWIK-STIK	Microbiologics Inc
2023-09-20	Z-2577-2023	Class II	BeamAdjust software Version 2	PTW-FREIBURG
2023-09-20	Z-2578-2023	Class II	ACL TOP Family 50 Series Models as follows: In vitro diagnostic…	Instrumentation Laboratory
2023-09-20	Z-2579-2023	Class II	Keystone Bosworth Copaliner Cavity Varnish	Keystone Industries
2023-09-20	Z-2580-2023	Class II	Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture…	Keystone Industries
2023-09-20	Z-2581-2023	Class II	Welch Allyn Connex Spot Monitor	Baxter Healthcare Corporation
2023-09-20	Z-2582-2023	Class II	ACUSON Redwood 2	Siemens Medical Solutions USA, Inc.
2023-09-20	Z-2587-2023	Class II	Philips Allura Xper	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2023-09-20	Z-2588-2023	Class II	FILMARRAY Gastrointestinal	BioFire Diagnostics, LLC
2023-09-13	Z-2402-2023	Class II	Allura Xper series	Philips Medical Systems Nederland B.V.
2023-09-13	Z-2403-2023	Class II	Azurion	Philips Medical Systems Nederland B.V.
2023-09-13	Z-2404-2023	Class II	MultiDiagnost-Eleva	Philips Medical Systems Nederland B.V.
2023-09-13	Z-2513-2023	Class II	Cook Lead Clipper- An auxiliary tool indicated for use in patients…	Cook Vandergrift, Inc.
2023-09-13	Z-2515-2023	Class II	ISee Ortho-K Lens	PARAGON VISION SCIENCES, Inc
2023-09-13	Z-2516-2023	Class II	Fargo Ortho-K Lens	PARAGON VISION SCIENCES, Inc
2023-09-13	Z-2517-2023	Class II	3D9-3v Transducer	Philips Ultrasound, Inc.
2023-09-13	Z-2518-2023	Class II	For intraventricular indications mainly used for operations within…	Aesculap Implant Systems LLC
2023-09-13	Z-2519-2023	Class II	M/L Taper Hip Prosthesis Extended Offset	Zimmer, Inc.
2023-09-13	Z-2521-2023	Class III	ZVU Functional GI Software	Diversatek Healthcare
2023-09-13	Z-2522-2023	Class II	Olympus Distal Attachment	Aomori Olympus Co., Ltd.
2023-09-13	Z-2523-2023	Class II	Reusable distal attachments Models: MH-462	Aomori Olympus Co., Ltd.
2023-09-06	Z-1268-2023	Class II	Atellica CH LDL Cholesterol Direct	Siemens Healthcare Diagnostics, Inc.
2023-09-06	Z-1269-2023	Class II	Atellica CH Total Protein II- In vitro diagnostic use in the…	Siemens Healthcare Diagnostics, Inc.
2023-09-06	Z-1270-2023	Class II	Atellica CH Triglycerides	Siemens Healthcare Diagnostics, Inc.
2023-09-06	Z-1271-2023	Class II	Atellica CH Triglycerides_2: in vitro diagnostic use in the…	Siemens Healthcare Diagnostics, Inc.
2023-09-06	Z-2431-2023	Class I	Cardiosave Hybrid Intra-Aortic Balloon Pumps	Datascope Corp.
2023-09-06	Z-2432-2023	Class I	Cardiosave Rescue Intra-Aortic Balloon Pumps	Datascope Corp.
2023-09-06	Z-2433-2023	Class I	Cardiosave Hybrid Intra-Aortic Balloon Pumps	Datascope Corp.
2023-09-06	Z-2434-2023	Class I	Cardiosave Rescue Intra-Aortic Balloon Pumps	Datascope Corp.
2023-09-06	Z-2435-2023	Class I	Cardiosave Hybrid Intra-Aortic Balloon Pumps	Datascope Corp.
2023-09-06	Z-2436-2023	Class I	Cardiosave Rescue Intra-Aortic Balloon Pumps	Datascope Corp.
2023-09-06	Z-2437-2023	Class I	Cardiosave Hybrid Intra-Aortic Balloon Pumps	Datascope Corp.
2023-09-06	Z-2438-2023	Class I	Cardiosave Rescue Intra-Aortic Balloon Pumps	Datascope Corp.
2023-09-06	Z-2463-2023	Class II	SurgiCount+ Software Application-indicated as an adjunctive…	Stryker Corporation
2023-09-06	Z-2464-2023	Class II	RayCare software	RAYSEARCH LABORATORIES AB
2023-09-06	Z-2465-2023	Class II	LifeSPARC Pump	Cardiac Assist, Inc
2023-09-06	Z-2466-2023	Class II	PORTEX 0	Smiths Medical ASD Inc.
2023-09-06	Z-2467-2023	Class II	EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V	Olympus Corporation of the Americas
2023-09-06	Z-2468-2023	Class II	The Chevalier Valvulotome is a device used to disrupt the valves of…	LeMaitre Vascular, Inc.
2023-09-06	Z-2469-2023	Class II	GS70 Salus Surgical Table	Skytron, LLC
2023-09-06	Z-2470-2023	Class II	GS70H Salus Surgical Table	Skytron, LLC
2023-09-06	Z-2471-2023	Class II	Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the…	Siemens Healthcare Diagnostics, Inc.
2023-09-06	Z-2472-2023	Class II	Atellica CH LDL Cholesterol- In vitro diagnostic use in the…	Siemens Healthcare Diagnostics, Inc.
2023-09-06	Z-2473-2023	Class II	Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in…	Siemens Healthcare Diagnostics, Inc.
2023-09-06	Z-2474-2023	Class II	Atellica¿ CH HDL Cholesterol- In vitro diagnostic use in the…	Siemens Healthcare Diagnostics, Inc.
2023-09-06	Z-2475-2023	Class II	LIF AMP	Alphatec Spine, Inc.
2023-09-06	Z-2476-2023	Class II	epoc BGEM BUN Test Card with epoc Host SW v3	Siemens Healthcare Diagnostics Inc
2023-09-06	Z-2477-2023	Class II	epoc BGEM Crea Test Card with epoc Host SW v3	Siemens Healthcare Diagnostics Inc
2023-09-06	Z-2478-2023	Class II	epoc BGEM Test Card	Siemens Healthcare Diagnostics Inc
2023-09-06	Z-2479-2023	Class II	PASCAL Precision Transcatheter Valve Repair System	Edwards Lifesciences, LLC
2023-09-06	Z-2480-2023	Class II	Visera Hysterovideoscope Olympus HYF Type V	Olympus Corporation of the Americas
2023-09-06	Z-2481-2023	Class II	Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the…	Waldemar Link GmbH & Co. KG (Mfg Site)
2023-09-06	Z-2482-2023	Class II	Oculus Pentacam AXL Wave	Oculus Optikgeraete GMBH
2023-09-06	Z-2483-2023	Class II	Oculus Pentacam AXL	Oculus Optikgeraete GMBH
2023-09-06	Z-2484-2023	Class II	Oculus Myopia Master	Oculus Optikgeraete GMBH
2023-09-06	Z-2485-2023	Class II	Wireless Foot Switch distributed with Philips Allura Xper and Azurion…	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2023-09-06	Z-2486-2023	Class II	Cardiosave Hybrid Intra-Aortic Balloon Pumps	Datascope Corp.
2023-09-06	Z-2487-2023	Class II	Cardiosave Rescue Intra-Aortic Balloon Pumps	Datascope Corp.
2023-09-06	Z-2488-2023	Class II	Beckman Coulter	Beckman Coulter Inc.
2023-09-06	Z-2489-2023	Class II	Upper roller bracket	Accuray Incorporated
2023-09-06	Z-2490-2023	Class II	Olympus Bronchovideoscope	Olympus Corporation of the Americas
2023-09-06	Z-2491-2023	Class II	Olympus Bronchovideoscope	Olympus Corporation of the Americas
2023-09-06	Z-2492-2023	Class II	Olympus Bronchovideoscope	Olympus Corporation of the Americas
2023-09-06	Z-2493-2023	Class II	Olympus Bronchovideoscope	Olympus Corporation of the Americas
2023-09-06	Z-2494-2023	Class II	Olympus Bronchovideoscope	Olympus Corporation of the Americas
2023-09-06	Z-2495-2023	Class II	Olympus Airway Mobilescope	Olympus Corporation of the Americas

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