FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 38 of 520
Moderate Feb 26, 2025
3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit VIAKIT07S05/AU - V.A.C. VIA Starter Kit 65-Pack …
KCI USA, INC.
Moderate Feb 26, 2025
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Remel, Inc
Moderate Feb 26, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.1…
RAYSEARCH LABORATORIES AB
Moderate Feb 26, 2025
Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.…
RAYSEARCH LABORATORIES AB
Moderate Feb 26, 2025
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
Dexcom, Inc.
Critical Feb 26, 2025
Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Critical Feb 26, 2025
Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Feb 26, 2025
3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US PRE3201US Prevena Plus Peel an…
KCI USA, INC.
Moderate Feb 26, 2025
DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement
DeRoyal Industries Inc
Moderate Feb 26, 2025
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
Dexcom, Inc.
Critical Feb 26, 2025
Allura CV20; Catalog numbers: 722031
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Feb 26, 2025
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 10.1.0.613 and 10.1.1.54 Software Version: …
RAYSEARCH LABORATORIES AB
Moderate Feb 26, 2025
AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,
Hollister Incorporated
Moderate Feb 26, 2025
AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,
Hollister Incorporated
Moderate Feb 26, 2025
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
Augustine Temperature Management, LLC
Critical Feb 26, 2025
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Critical Feb 26, 2025
Intact Vascular Tack Endovascular System, to treat vascular dissections with Tack implant(s) following angioplasty: (4F,1.5-4.5mm), 150cm, REF: 15415…
Spectranetics Corporation
Moderate Feb 26, 2025
Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, Model Number DYNJAA254A; 2) ADULT MAIN DISP. INTUB PART A, Model Number …
MEDLINE INDUSTRIES, LP - Northfield
Critical Feb 26, 2025
Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
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
Critical Feb 26, 2025
Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Critical Feb 26, 2025
Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
Moderate Feb 26, 2025
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
MEDLINE INDUSTRIES, LP - Northfield
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
Moderate Feb 26, 2025
AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,
Hollister Incorporated
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
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
Critical Feb 26, 2025
Allura Xper FD20/15; Catalog numbers: 722058
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Critical Feb 26, 2025
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Critical Feb 26, 2025
Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
Critical Feb 26, 2025
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
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.
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
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
Moderate Feb 19, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet), REF 8234; in-vitro diagnostic test
Microbiologics Inc
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.
Moderate Feb 19, 2025
Microbiologics Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet), REF 8235; in-vitro diagnostic test
Microbiologics Inc
Moderate Feb 19, 2025
MOSAIQ Oncology Information System
Elekta, Inc.
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
Moderate Feb 19, 2025
stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades
Stryker Corporation
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.
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.
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
Moderate Feb 19, 2025
Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00
Murata Vios, Inc.
Moderate Feb 19, 2025
Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;
Cardinal Health 200, LLC
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.