Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 40 of 548
FDA Devices Critical Feb 26, 2025
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Feb 26, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Feb 26, 2025
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
Augustine Temperature Management, LLC
FDA Devices Critical Feb 26, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Critical Feb 26, 2025
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Feb 26, 2025
Irix-A Integrated Lumbar Fusion System, Model Number X080-423011-08PC (Spacer Assy, 42 X 30 X 8¿, 11mm, PC (STERILE)) and Model Number X080-382819-08…
XTANT Medical Holdings, Inc
FDA Devices Moderate Feb 26, 2025
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Feb 26, 2025
Brand Name: RayStation Intended as a Radiation Therapy Treatment Planning System. Model/Catalog Number: 7.0.0.19, 8.0.0.61, 8.0.1.10 Software Ver…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Feb 26, 2025
AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
Hollister Incorporated
FDA Devices Moderate Feb 26, 2025
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Feb 26, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 6.1.1.2, 6.2.0.7, 6.3.0.6 Software Version:…
RAYSEARCH LABORATORIES AB
FDA Devices Critical Feb 26, 2025
Allura Xper FD20/15; Catalog numbers: 722058
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Critical Feb 26, 2025
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Critical Feb 26, 2025
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Feb 26, 2025
Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138 used in conjunction with Warming Blankets and Mattresses.
Augustine Temperature Management, LLC
FDA Devices Critical Feb 26, 2025
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Feb 19, 2025
Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NS…
Cardinal Health 200, LLC
FDA Devices Moderate Feb 19, 2025
Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Gel Model/Catalog Number: 31815 Software Version: N/A Product Descripti…
Integra LifeSciences Corp.
FDA Devices Moderate Feb 19, 2025
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23D…
Cardinal Health 200, LLC
FDA Devices Critical Feb 19, 2025
Olympus Single Use Guide Sheath Kits with the following product descriptions and model numbers: 1. Single Use Guide Sheath Kit K-201 2.0MM Channel…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 19, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Microbiologics Inc
FDA Devices Moderate Feb 19, 2025
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H 32MM …
Exactech, Inc.
FDA Devices Moderate Feb 19, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Microbiologics Inc
FDA Devices Moderate Feb 19, 2025
MOSAIQ Oncology Information System
Elekta, Inc.
FDA Devices Moderate Feb 19, 2025
Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY…
Cardinal Health 200, LLC
FDA Devices Moderate Feb 19, 2025
stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Stryker Corporation
FDA Devices Moderate Feb 19, 2025
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpose of th…
MICROVENTION INC.
FDA Devices Moderate Feb 19, 2025
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4)…
CareFusion 303, Inc.
FDA Devices Critical Feb 19, 2025
Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction with the SmartDrive MX2+ Wheelchair Power Assist component.
Max Mobility LLC
FDA Devices Moderate Feb 19, 2025
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Murata Vios, Inc.
FDA Devices Moderate Feb 19, 2025
Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Cardinal Health 200, LLC
FDA Devices Moderate Feb 19, 2025
BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
CareFusion 303, Inc.
FDA Devices Moderate Feb 19, 2025
Brand Name: The Guardian System Product Name: The Guardian Model/Catalog Number: Model AMSG3-E Product Description: The Guardian is a cardiac diagnos…
Angel Medical Systems, Inc.
FDA Devices Moderate Feb 19, 2025
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests,…
HF Acquisition Co LLC
FDA Devices Moderate Feb 19, 2025
Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KI…
Cardinal Health 200, LLC
FDA Devices Moderate Feb 19, 2025
Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D …
Cardinal Health 200, LLC
FDA Devices Critical Feb 19, 2025
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For use during …
Getinge Usa Sales Inc
FDA Devices Moderate Feb 19, 2025
Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1…
Exactech, Inc.
FDA Devices Moderate Feb 19, 2025
Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2…
Cardinal Health 200, LLC
FDA Food Moderate Feb 12, 2025
item 8201866 JUST BAKED PUMPKIN CAKE RINGS 144x2.45 OZ, NET WT 22.05 LB
FGF, LLC
FDA Food Moderate Feb 12, 2025
item 8201867 JUST BAKED PUMPKIN CAKE MUNCHKINS 440x0.47 OZ, NET WT 12.93 LB
FGF, LLC
FDA Devices Moderate Feb 12, 2025
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications wi…
Medicrea International
FDA Devices Moderate Feb 12, 2025
Azurion 3 M12 System Code: (1) 722063 (2) 722221
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Feb 12, 2025
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
LivaNova USA, Inc.
FDA Devices Moderate Feb 12, 2025
Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;
New Medical Technologies Gmbh
FDA Devices Moderate Feb 12, 2025
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/o…
Ethicon, LLC
FDA Devices Moderate Feb 12, 2025
IntelliVue Patient Monitor MX400. Model Number: 866060
Philips North America Llc
FDA Devices Moderate Feb 12, 2025
Optima XR646 HD. X-Ray imaging system.
GE Medical Systems, LLC
FDA Devices Moderate Feb 12, 2025
IntelliVue Patient Monitor MX450. Model Number: 866062
Philips North America Llc
FDA Devices Moderate Feb 12, 2025
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
LivaNova USA, Inc.