Medical Devices Recalls

Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.

Philips North America

Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, Kit SKU DYNJ0…

Medline Industries, LP

Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.

Philips North America

AlternatiV+ Max Knotless Anchor

Aju Pharm Co., Ltd.

Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Produc…

SunMed Holdings, LLC

Scepter Fuel Containers Recalled Due to Risk of Serious Injury or Death from Flash Fire, Burn and Child Poisoning; Violates Mandatory Standards for P…

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 …

RAYSEARCH LABORATORIES AB

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStatio…

RAYSEARCH LABORATORIES AB

Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors…

Edan Diagnostics

Philips Azurion system; Software Version Number: R3.1;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device inte…

Edan Diagnostics

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 20…

RAYSEARCH LABORATORIES AB

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radi…

RAYSEARCH LABORATORIES AB

Allwell Inflation Device, for angiographic use REF: IS-30-A

Merit Medical Systems, Inc.

Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS …

Edan Diagnostics

MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L

Medline Industries, LP

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device int…

Edan Diagnostics

Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN41…

Merit Medical Systems, Inc.

Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG…

Edan Diagnostics

MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO

Medline Industries, LP

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors includin…

Edan Diagnostics

ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

ICU Medical, Inc.

Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

ICU Medical, Inc.

ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)

ICU Medical, Inc.

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor in…

Edan Diagnostics

GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni…

GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING

MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.

Medline Industries, LP

Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting i…

Community Products, LLC

RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation…

RAYSEARCH LABORATORIES AB

Merit Medical , Custom Manifold Kit REF: K09-13203A

Merit Medical Systems, Inc.

Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261

Merit Medical Systems, Inc.

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A,…

RAYSEARCH LABORATORIES AB

Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.69…

Tyber Medical

Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the si…

Community Products, LLC

Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform l…

Edan Diagnostics

RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2,…

RAYSEARCH LABORATORIES AB

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and …

Edan Diagnostics

Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MH…

LEASEIR TECHNOLOGIES SLU

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

Baxter Healthcare Corporation

MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO

Medline Industries, LP

Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C…

Merit Medical Systems, Inc.

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring …

Edan Diagnostics

ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)

ICU Medical, Inc.

MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L

Medline Industries, LP

Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Ra…

RAYSEARCH LABORATORIES AB

Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B

Merit Medical Systems, Inc.

Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital sign…

Edan Diagnostics

Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description…

MicroPort Orthopedics Inc.

Thrasio Recalls Angry Orange Enzyme Stain Removers Due to Risk of Exposure to Bacteria

Thrasio, LLC, of Boston, Massachusetts

MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)

Elekta, Inc.