Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE KIT, Kit SKU P903933B
Medical Devices·60 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, Kit SKU DYNJ35494C; 2) SMJ C-SECTION PACK-LF, Kit SKU DYNJ...
Medical Devices·96 affected·Dec 12, 2025
High RiskFDA
Hologic, Inc
ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution.
Medical Devices·3,728 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEURO-LF, Kit SKU DYNJ20028L; 2) NEURO MINOR PACK, Kit SKU DY...
Medical Devices·236 affected·Dec 12, 2025
High RiskFDA
Medline Industries, Lp
Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCOPY PACK-LF, Kit SKU DYNJ0395022O; 2) PELVISCOPY PACK-LF, K...
Medical Devices·1,928 affected·Dec 12, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes the following label descriptions and corresponding models: ...
Medical Devices·10,466 affected·Dec 12, 2025
High RiskFDA
Applied Medical Resources Corp
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Medical Devices·450 affected·Dec 11, 2025
High RiskFDA
Fujirebio Diagnostics, Inc.
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description...
Medical Devices·117 affected·Dec 11, 2025
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Medical Devices·1 affected·Dec 10, 2025
CriticalFDA
Repligen Corporation
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Medical Devices·33 affected·Dec 10, 2025
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
SMV DSI, System, Tomography, Computed, Emission
Medical Devices·3 affected·Dec 10, 2025
High RiskFDA
Heraeus Medical Gmbh (dental Division)
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A ...
Medical Devices·0 affected·Dec 9, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 7222...
Medical Devices·990 affected·Dec 8, 2025
High RiskFDA
Imris Imaging Inc
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 1138...
Medical Devices·122 affected·Dec 8, 2025
High RiskFDA
Beaver-visitec International, Inc.
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Medical Devices·5 affected·Dec 5, 2025
High RiskFDA
Siemens Medical Solutions Usa, Inc
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Medical Devices·1 affected·Dec 5, 2025
High RiskFDA
Merit Medical Systems, Inc.
Allwell Inflation Device, for angiographic use REF: IS-30-A
Medical Devices·173,645 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4...
Medical Devices·4,163,123 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical , Custom Manifold Kit REF: K09-13203A
Medical Devices·2,192 affected·Dec 4, 2025
High RiskFDA
Mobius Imaging, Llc
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Medical Devices·101 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Medical Devices·864 affected·Dec 4, 2025
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A...
Medical Devices·18,897 affected·Dec 4, 2025
High RiskFDA
Philips North America
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.
Medical Devices·1 affected·Dec 3, 2025
High RiskFDA
Philips Healthcare (suzhou) Co., Ltd.
Philips Incisive CT
Medical Devices·35 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Medical Devices·1 affected·Dec 3, 2025
High RiskFDA
Carefusion 303, Inc.
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421...
Medical Devices·2,079 affected·Dec 3, 2025
High RiskFDA
Medtronic Neuromodulation
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and o...
Medical Devices·7,123 affected·Dec 3, 2025
High RiskFDA
Philips North America
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Medical Devices·3 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.
Medical Devices·24 affected·Dec 3, 2025
High RiskFDA
Philips North America
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.
Medical Devices·9 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.
Medical Devices·6 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.
Medical Devices·31 affected·Dec 3, 2025
High RiskFDA
Philips North America
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.
Medical Devices·1 affected·Dec 3, 2025
High RiskFDA
Philips North America
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.
Medical Devices·3 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.
Medical Devices·21 affected·Dec 3, 2025
High RiskFDA
Philips North America
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
Medical Devices·5 affected·Dec 3, 2025
High RiskFDA
Philips North America
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
Medical Devices·6 affected·Dec 3, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Softwa...
Medical Devices·22 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Softwa...
Medical Devices·23 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Softwa...
Medical Devices·23 affected·Dec 2, 2025
High RiskFDA
Microbiologics Inc
KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
Medical Devices·86 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Softwa...
Medical Devices·22 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Softwa...
Medical Devices·3 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Softwa...
Medical Devices·11 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Softwa...
Medical Devices·23 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Softwa...
Medical Devices·22 affected·Dec 2, 2025
High RiskFDA
Zimmer, Inc.
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Softwa...
Medical Devices·23 affected·Dec 2, 2025
High RiskFDA
Microbiologics Inc
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Medical Devices·18 affected·Dec 2, 2025