FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 4 of 520
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.
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.
Moderate Jan 21, 2026
Allura Xper FD10F; Model Number: 722002;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
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)
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
Moderate Jan 21, 2026
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Medicrea International
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
Moderate Jan 21, 2026
Allura Xper FD10/10; Model Number: 722027;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Jan 21, 2026
Allura Xper FD20; Model Number: 722028;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Jan 21, 2026
Product Name: Allura Xper FD10C; Model number: 722001;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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.
Moderate Jan 21, 2026
Allura Xper FD10; Model Number: 722003;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
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
Moderate Jan 21, 2026
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Mobius Imaging, LLC
Moderate Jan 21, 2026
Allura Xper FD10/10; Model Number: 722011;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
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
Moderate Jan 21, 2026
Allura Xper FD20/20; Model Number: 722038;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
Moderate Jan 21, 2026
Allura Xper FD10/10; Model Number: 722005;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Jan 21, 2026
Allura Xper FD20; Model Number: 722012;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Moderate Jan 21, 2026
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
ICU Medical Inc.
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
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.
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.
Moderate Jan 21, 2026
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Hologic, Inc
Moderate Jan 21, 2026
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Canon Medical System, USA, INC.
Moderate Jan 21, 2026
Allura Xper FD20/10; Model Number: 722029;
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
Moderate Jan 21, 2026
SMV DSI, System, Tomography, Computed, Emission
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
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.
Moderate Jan 21, 2026
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Fresenius Kabi USA, LLC
Moderate Jan 21, 2026
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Mobius Imaging, LLC
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
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)
Moderate Jan 14, 2026
Philips Incisive CT
Philips Healthcare (Suzhou) Co., Ltd.
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.
Moderate Jan 14, 2026
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Sophysa
Moderate Jan 14, 2026
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Applied Medical Resources Corp
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
Moderate Jan 14, 2026
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Beckman Coulter, Inc.
Moderate Jan 14, 2026
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Beckman Coulter, Inc.
Critical Jan 14, 2026
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
AVID Medical, Inc.
Critical Jan 14, 2026
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
AVID Medical, Inc.
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
Moderate Jan 14, 2026
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Meridian Bioscience Inc
Moderate Jan 14, 2026
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. …
Remote Diagnostic Technologies Ltd.
Moderate Jan 14, 2026
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Siemens Medical Solutions USA, Inc