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15,654 recalls
High RiskFDA
Synthes (usa) Products Llc
LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral N...
Medical Devices·120 affected·Sep 26, 2025
High RiskFDA
Asp Global, Llc. Dba Anatomy Supply Partners, Llc.
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator; Red Model/Catalog Number: 07 7151 Product Descri...
Medical Devices·6,600 affected·Sep 26, 2025
High RiskFDA
Asp Global, Llc. Dba Anatomy Supply Partners, Llc.
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L; Plastic, Ammonium Heparinized, Red Marking Model/Catalog Number: 06 0507 Product ...
Medical Devices·2,000 affected·Sep 26, 2025
High RiskFDA
Asp Global, Llc. Dba Anatomy Supply Partners, Llc.
SAFE-T-FILL Magnetic Rings for SAFE-T-FILL Blood Gas Capillaries, Model 07 9502
Medical Devices·16,920 affected·Sep 26, 2025
High RiskFDA
Asp Global, Llc. Dba Anatomy Supply Partners, Llc.
SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L; Prepared with Clot Activator; Amber Microtube, Red Model/Catalog Number: 07 7450 ...
Medical Devices·1,500 affected·Sep 26, 2025
High RiskFDA
Ge Healthcare Finland Oy
BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-001 Manufacturer Part Number U80296-...
Medical Devices·2,857 affected·Sep 26, 2025
High RiskFDA
Asp Global, Llc. Dba Anatomy Supply Partners, Llc.
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07...
Medical Devices·64,850 affected·Sep 26, 2025
High RiskFDA
Philips Medical Systems
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
Medical Devices·1 affected·Sep 25, 2025
High RiskFDA
Covidien, Lp
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX LOBECTOMIA VATS 3D; CFN: BOX06170V4;
Medical Devices·2 affected·Sep 25, 2025
High RiskFDA
Philips Medical Systems
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
Medical Devices·165 affected·Sep 25, 2025
CriticalFDA
Balt Usa, Llc
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100...
Medical Devices·207 affected·Sep 25, 2025
High RiskFDA
Philips Medical Systems
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
Medical Devices·105 affected·Sep 25, 2025
High RiskFDA
Covidien, Lp
Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN: SIGSDL45CTVT;
Medical Devices·3,263 affected·Sep 25, 2025
CriticalFDA
Djo, Llc
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02
Medical Devices·1,594 affected·Sep 25, 2025
High RiskFDA
Aesculap Inc
Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Produc...
Medical Devices·26 affected·Sep 24, 2025
High RiskFDA
Aesculap Inc
Brand Name: AESCULAP Product Name: REDUCING CONVERTER 10/12MM TO 5MM Model/Catalog Number: EK087P Software Version: N/A Product Descr...
Medical Devices·155 affected·Sep 24, 2025
High RiskFDA
Becton Dickinson & Co.
BD EpiCenter Microbiology Data Management System, labeled as the following: 1. Computer System Epicenter F/G, Catalog Number: 441002. ...
Medical Devices·2,050 affected·Sep 23, 2025
High RiskFDA
Becton Dickinson & Co.
BD BACTEC Blood Culture System, labeled as the following: 1. BACTEC 9120 System, Catalog Numbers: 445570, 445702. 2. INSTRUMENT BA...
Medical Devices·1,086 affected·Sep 23, 2025
High RiskFDA
Total Joint Orthopedics, Inc.
Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic ...
Medical Devices·103 affected·Sep 23, 2025
High RiskFDA
Cardinal Health 200, Llc
Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stomach Tube, Radiopaque Line, 10 Fr/Ch (3...
Medical Devices·0 affected·Sep 18, 2025
High RiskFDA
Ge Medical Systems, Llc
LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535
Medical Devices·31 affected·Sep 18, 2025
High RiskFDA
Cardinal Health 200, Llc
Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 Fr/Ch (4.0 mm) 264945 Salem Sump" S...
Medical Devices·0 affected·Sep 18, 2025
High RiskFDA
Cardinal Health 200, Llc
Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, 10 Fr/Ch (3.3 mm) x 90 cm 118026441...
Medical Devices·0 affected·Sep 18, 2025
High RiskFDA
Cardinal Health 200, Llc
Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marked 8888266197 Salem Sump" Anti-Reflux...
Medical Devices·0 affected·Sep 18, 2025
CriticalFDA
Cook Medical Incorporated
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167...
Medical Devices·695 affected·Sep 18, 2025
High RiskFDA
Abbott Laboratories
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for O...
Medical Devices·833 affected·Sep 18, 2025
High RiskFDA
Fisher & Paykel Healthcare, Ltd.
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Medical Devices·51,144 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP....
Medical Devices·5,770 affected·Sep 18, 2025
High RiskFDA
Ge Medical Systems, Llc
LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533
Medical Devices·37 affected·Sep 18, 2025
High RiskFDA
B Braun Medical Inc
Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWEN...
Medical Devices·2,450 affected·Sep 18, 2025
High RiskFDA
Baxter Healthcare Corporation
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 01690-400) Thermomete...
Medical Devices·5,209 affected·Sep 17, 2025
High RiskFDA
Cpm Medical Consultants, Llc.
Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401, OS328017, OS200020L, OS200025L, OS200120L, OS200125, ...
Medical Devices·3,317 affected·Sep 17, 2025
High RiskFDA
Enterix, Inc.
InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure O...
Medical Devices·201,426 affected·Sep 17, 2025
CriticalFDA
Abiomed, Inc.
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product ...
Medical Devices·9,177 affected·Sep 16, 2025
High RiskFDA
Alcon Research Llc
CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTA...
Medical Devices·28,323 affected·Sep 15, 2025
High RiskFDA
Uih Technologies Llc
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
Medical Devices·2 affected·Sep 12, 2025
High RiskFDA
Uih Technologies Llc
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
Medical Devices·3 affected·Sep 12, 2025
High RiskFDA
Uih Technologies Llc
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
Medical Devices·95 affected·Sep 12, 2025
High RiskFDA
Uih Technologies Llc
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
Medical Devices·22 affected·Sep 12, 2025
High RiskFDA
Uih Technologies Llc
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
Medical Devices·11 affected·Sep 12, 2025
High RiskFDA
Argon Medical Devices, Inc
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevent...
Medical Devices·1,821 affected·Sep 12, 2025
High RiskFDA
Diagnostica Stago, Inc.
Product: STA Liatest D-Di; REF: 00515;
Medical Devices·12,740 affected·Sep 12, 2025
High RiskFDA
Uih Technologies Llc
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
Medical Devices·2 affected·Sep 12, 2025
High RiskFDA
Uih Technologies Llc
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx...
Medical Devices·4 affected·Sep 12, 2025
High RiskFDA
Medline Industries, Lp
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Medical Devices·8,267,150 affected·Sep 11, 2025
CriticalFDA
Olympus Corporation Of The Americas
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Medical Devices·262 affected·Sep 11, 2025
CriticalFDA
Carefusion 303, Inc.
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite...
Medical Devices·0 affected·Sep 11, 2025
CriticalFDA
Olympus Corporation Of The Americas
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
Medical Devices·116 affected·Sep 11, 2025