Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Intuitive Surgical, Inc.
8MM,FORCE BIPOLAR,IS4000 REF 471405
Medical Devices·46,759 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27000L,Uretero-Renoscope, 7 Fr., 6¿, 43 cm, NON STERILE, RxONLY, CE 0123
Medical Devices·65 affected·Dec 19, 2024
High RiskFDA
Jinan Bodor Cnc Machine Co Ltd
Bodor P and C series laser cutting machines
Medical Devices·269 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296
Medical Devices·29,723 affected·Dec 19, 2024
High RiskFDA
Intuitive Surgical, Inc.
8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344
Medical Devices·3,869 affected·Dec 19, 2024
High RiskFDA
Karl Storz Endoscopy
KARL STORZ - ENDOSKOPE, REF: 27002K, Ureteroscope, 9.5 Fr., 6¿, 34 cm, NON STERILE, RxONLY, CE 0123
Medical Devices·180 affected·Dec 19, 2024
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission
Medical Devices·116 affected·Dec 18, 2024
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Em...
Medical Devices·36 affected·Dec 18, 2024
High RiskFDA
Encore Medical, Lp
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Medical Devices·33 affected·Dec 18, 2024
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
Medical Devices·8 affected·Dec 18, 2024
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100P...
Medical Devices·76 affected·Dec 18, 2024
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Discovery NM/CT 670 ES, Model/Catalog Numbers: 1) H3100XF ; System, Tomography, Computed, Emission
Medical Devices·17 affected·Dec 18, 2024
High RiskFDA
Ge Medical Systems Israel, Functional Imaging
GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, ...
Medical Devices·859 affected·Dec 18, 2024
CriticalFDA
Medline Industries, Lp - Northfield
Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIK...
Medical Devices·3,930 affected·Dec 16, 2024
High RiskFDA
Augustine Temperature Management, Llc
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia
Medical Devices·1 affected·Dec 16, 2024
High RiskFDA
Augustine Temperature Management, Llc
Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia
Medical Devices·4 affected·Dec 16, 2024
High RiskFDA
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software ...
Medical Devices·5,940 affected·Dec 13, 2024
High RiskFDA
Trinity Sterile, Inc.
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Ver...
Medical Devices·1,980 affected·Dec 13, 2024
High RiskFDA
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Ca...
Medical Devices·3,960 affected·Dec 13, 2024
High RiskFDA
Trinity Sterile, Inc.
Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Numb...
Medical Devices·1,980 affected·Dec 13, 2024
High RiskFDA
Livanova Usa, Inc.
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Medical Devices·81,606 affected·Dec 12, 2024
High RiskFDA
Livanova Usa, Inc.
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Medical Devices·48 affected·Dec 12, 2024
CriticalFDA
Abiomed, Inc.
Impella RP Flex with SmartAssist; Product Number: 1000323;
Medical Devices·2,364 affected·Dec 12, 2024
High RiskFDA
Medtronic Perfusion Systems
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Medical Devices·745 affected·Dec 12, 2024
CriticalFDA
Boston Scientific Corporation
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
Medical Devices·156,329 affected·Dec 12, 2024
CriticalFDA
Nuwellis Inc
nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFl...
Medical Devices·845 affected·Dec 11, 2024
High RiskFDA
Hf Acquisition Co Llc
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring Syste...
Medical Devices·4,021 affected·Dec 11, 2024
High RiskFDA
Encore Medical, Lp
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Medical Devices·9 affected·Dec 10, 2024
CriticalFDA
Fresenius Kabi Usa, Llc
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Medical Devices·1,520 affected·Dec 6, 2024
High RiskFDA
Ge Medical Systems, Llc
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Soluti...
Medical Devices·7 affected·Dec 6, 2024
High RiskFDA
Medtronic Navigation, Inc.
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percuta...
Medical Devices·67,370 affected·Dec 4, 2024
High RiskFDA
Medicrea International
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software app...
Medical Devices·1,548 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERI...
Medical Devices·75 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STE...
Medical Devices·300 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE ...
Medical Devices·245,015 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STE...
Medical Devices·0 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Medical Devices·0 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STER...
Medical Devices·175 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
Medical Devices·0 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STE...
Medical Devices·150 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO S...
Medical Devices·41,850 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological pro...
Medical Devices·40 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/...
Medical Devices·2,500 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple ...
Medical Devices·125 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery
Medical Devices·0 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STE...
Medical Devices·1,050 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERIL...
Medical Devices·475 affected·Dec 3, 2024
High RiskFDA
Sklar Instruments
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SC...
Medical Devices·350 affected·Dec 3, 2024