Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 4 of 548
FDA Devices Moderate Jan 21, 2026
VANTAGE GALAN 3T Model MRT-3020/MEXL-3020
Canon Medical System, USA, INC.
FDA Devices Moderate Jan 21, 2026
Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G
Medline Industries, LP
FDA Devices Moderate Jan 21, 2026
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Intuitive Surgical, Inc.
FDA Devices Moderate Jan 21, 2026
BD Ready-to-Use Hydrophilic Catheter 14 Fr (4.7 mm) Straight Tip, Coated, Female REF: RTU14F
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
FDA Devices Moderate Jan 21, 2026
Allura Xper FD10F; Model Number: 722002;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ5448…
Medline Industries, LP
FDA Devices Moderate Jan 21, 2026
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Des…
Heraeus Medical GmbH (Dental Division)
FDA Devices Moderate Jan 21, 2026
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on S…
Medtronic Neuromodulation
FDA Devices Moderate Jan 21, 2026
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Medicrea International
FDA Devices Moderate Jan 21, 2026
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC0102…
Medline Industries, LP
FDA Devices Moderate Jan 21, 2026
Allura Xper FD10/10; Model Number: 722027;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Allura Xper FD20; Model Number: 722028;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Product Name: Allura Xper FD10C; Model number: 722001;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. A…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Allura Xper FD10; Model Number: 722003;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVI…
Medline Industries, LP
FDA Devices Moderate Jan 21, 2026
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) PRE OP KIT, Medline kit SKU DYKS1093B; 2) P…
Medline Industries, LP
FDA Devices Moderate Jan 21, 2026
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Mobius Imaging, LLC
FDA Devices Moderate Jan 21, 2026
Allura Xper FD10/10; Model Number: 722011;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2…
Medline Industries, LP
FDA Devices Moderate Jan 21, 2026
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
REPLIGEN CORPORATION
FDA Devices Moderate Jan 21, 2026
Allura Xper FD20/20; Model Number: 722038;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: AN01 CAROTID ANESTH KIT-LF, Medline Kit SKU PHS972…
Medline Industries, LP
FDA Devices Moderate Jan 21, 2026
Allura Xper FD10/10; Model Number: 722005;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Allura Xper FD20; Model Number: 722012;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
ICU Medical Inc.
FDA Devices Moderate Jan 21, 2026
Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP …
Medline Industries, LP
FDA Devices Moderate Jan 21, 2026
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti…
Diagnostica Stago, Inc.
FDA Devices Critical Jan 21, 2026
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Gl…
Abbott Diabetes Care, Inc.
FDA Devices Moderate Jan 21, 2026
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Hologic, Inc
FDA Devices Moderate Jan 21, 2026
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Canon Medical System, USA, INC.
FDA Devices Moderate Jan 21, 2026
Allura Xper FD20/10; Model Number: 722029;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) A…
Medline Industries, LP
FDA Devices Moderate Jan 21, 2026
SMV DSI, System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
FDA Devices Moderate Jan 21, 2026
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: 1. Azurion…
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Jan 21, 2026
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Fresenius Kabi USA, LLC
FDA Devices Moderate Jan 21, 2026
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Mobius Imaging, LLC
FDA Devices Moderate Jan 14, 2026
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Vision RT Ltd
FDA Devices Moderate Jan 14, 2026
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is requir…
Integra LifeSciences Corp. (NeuroSciences)
FDA Devices Moderate Jan 14, 2026
Philips Incisive CT
Philips Healthcare (Suzhou) Co., Ltd.
FDA Devices Moderate Jan 14, 2026
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-…
CareFusion 303, Inc.
FDA Devices Moderate Jan 14, 2026
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Sophysa
FDA Devices Moderate Jan 14, 2026
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Applied Medical Resources Corp
FDA Devices Moderate Jan 14, 2026
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB S…
Medline Industries, LP
FDA Devices Moderate Jan 14, 2026
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Beckman Coulter, Inc.
FDA Devices Moderate Jan 14, 2026
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Beckman Coulter, Inc.
FDA Devices Critical Jan 14, 2026
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
AVID Medical, Inc.
FDA Devices Critical Jan 14, 2026
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
AVID Medical, Inc.
FDA Devices Moderate Jan 14, 2026
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 1138…
IMRIS Imaging Inc
FDA Devices Moderate Jan 14, 2026
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Meridian Bioscience Inc