FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 3 of 520
Moderate Feb 4, 2026
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
Moderate Feb 4, 2026
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
Moderate Feb 4, 2026
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
Philips North America
Moderate Feb 4, 2026
AlternatiV+ Max Knotless Anchor
Aju Pharm Co., Ltd.
Critical Feb 4, 2026
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Produc…
SunMed Holdings, LLC
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors…
Edan Diagnostics
Moderate Jan 28, 2026
Philips Azurion system; Software Version Number: R3.1;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radi…
RAYSEARCH LABORATORIES AB
Moderate Jan 28, 2026
Allwell Inflation Device, for angiographic use REF: IS-30-A
Merit Medical Systems, Inc.
Moderate Jan 28, 2026
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
Critical Jan 28, 2026
MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
Medline Industries, LP
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
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.
Moderate Jan 28, 2026
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG…
Edan Diagnostics
Critical Jan 28, 2026
MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO
Medline Industries, LP
Moderate Jan 28, 2026
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors includin…
Edan Diagnostics
Moderate Jan 28, 2026
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
ICU Medical, Inc.
Moderate Jan 28, 2026
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
ICU Medical, Inc.
Moderate Jan 28, 2026
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
ICU Medical, Inc.
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
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
Critical Jan 28, 2026
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
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
Merit Medical , Custom Manifold Kit REF: K09-13203A
Merit Medical Systems, Inc.
Moderate Jan 28, 2026
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Merit Medical Systems, Inc.
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform l…
Edan Diagnostics
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
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
Moderate Jan 28, 2026
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Baxter Healthcare Corporation
Critical Jan 28, 2026
MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
Medline Industries, LP
Moderate Jan 28, 2026
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.
Moderate Jan 28, 2026
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring …
Edan Diagnostics
Moderate Jan 28, 2026
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
ICU Medical, Inc.
Critical Jan 28, 2026
MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
Medline Industries, LP
Moderate Jan 28, 2026
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Ra…
RAYSEARCH LABORATORIES AB
Moderate Jan 28, 2026
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Merit Medical Systems, Inc.
Moderate Jan 28, 2026
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital sign…
Edan Diagnostics
Moderate Jan 28, 2026
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description…
MicroPort Orthopedics Inc.
Moderate Jan 21, 2026
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Elekta, Inc.
Moderate Jan 21, 2026
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Canon Medical System, USA, INC.
Moderate Jan 21, 2026
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Medline Industries, LP