Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Philips North America Llc
Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm L...
Medical Devices·486,631 affected·Apr 7, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Medical Devices·996 affected·Apr 7, 2025
High RiskFDA
Science & Bio Materials
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Medical Devices·30 affected·Apr 7, 2025
CriticalFDA
Baxter Healthcare Corporation
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; 5) RMS010093CP.
Medical Devices·4,174 affected·Apr 7, 2025
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. ...
Medical Devices·908 affected·Apr 3, 2025
High RiskFDA
Wandercraft Sas
Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-free, in rehabili...
Medical Devices·3 affected·Apr 3, 2025
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 -...
Medical Devices·1,771 affected·Apr 3, 2025
High RiskFDA
Medtronic Neuromodulation
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Medical Devices·534 affected·Apr 3, 2025
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2...
Medical Devices·1,180 affected·Apr 3, 2025
High RiskFDA
Getinge Disinfection Ab
Washer Disinfector Aquadis 56; Model Number: 56M
Medical Devices·424 affected·Apr 2, 2025
High RiskFDA
Getinge Disinfection Ab
Washer Disinfector Aquadis 56; Model Number: 56A
Medical Devices·102 affected·Apr 2, 2025
High RiskFDA
Iba Dosimetry Gmbh
myQA iON; Article Number: MQ10-000;
Medical Devices·84 affected·Apr 1, 2025
High RiskFDA
Philips North America Llc
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Medical Devices·630 affected·Apr 1, 2025
High RiskFDA
Belmont Instrument Llc
3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-0...
Medical Devices·603 affected·Mar 31, 2025
High RiskFDA
Avid Medical, Inc.
Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
Medical Devices·72 affected·Mar 31, 2025
High RiskFDA
Ultra Clean Systems, Inc.
Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic cleaning system
Medical Devices·96 affected·Mar 31, 2025
High RiskFDA
Avid Medical, Inc.
Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
Medical Devices·72 affected·Mar 31, 2025
High RiskFDA
Belmont Instrument Llc
Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The ...
Medical Devices·158 affected·Mar 31, 2025
High RiskFDA
Ihb Operations B.v.
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
Medical Devices·112 affected·Mar 27, 2025
CriticalFDA
Bausch & Lomb Surgical, Inc.
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Medical Devices·48,237 affected·Mar 27, 2025
High RiskFDA
Conformis Inc.
restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Medical Devices·16 affected·Mar 25, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Master/Nova, Model Number: 781106;
Medical Devices·103 affected·Mar 24, 2025
CriticalFDA
Baxter Healthcare Corporation
Welch Allyn Connex Vital Signs Monitor (CVSM):
Medical Devices·228,412 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
SmartPath to dStream for 3.0T, Model Number: 782145;
Medical Devices·4 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Explorer/Nova Dual, Model Number: 781108;
Medical Devices·12 affected·Mar 24, 2025
High RiskFDA
Boston Scientific Corporation
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a ...
Medical Devices·31 affected·Mar 24, 2025
CriticalFDA
Baxter Healthcare Corporation
Welch Allyn CONNEX Accessory Power Management Stand:
Medical Devices·114,202 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
SmartPath to dStream for 1.5T, Model Number: 782146;
Medical Devices·3 affected·Mar 24, 2025
High RiskFDA
Boston Scientific Corporation
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a ve...
Medical Devices·67 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.0T Omni/Stellar, Model Number: 781102;
Medical Devices·37 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Enterprise 1.5T, Model Number: 781145;
Medical Devices·34 affected·Mar 24, 2025
High RiskFDA
Boston Scientific Corporation
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a v...
Medical Devices·435 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Omni/Stellar, Model Number: 781104;
Medical Devices·26 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 0.5T Standard, Model Number: 781101;
Medical Devices·14 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 3.0T Quasar Dual, Model Number: 781150;
Medical Devices·12 affected·Mar 24, 2025
High RiskFDA
Philips Medical Systems Nederland B.v.
Intera 1.5T Power/Pulsar, Model Number: 781105;
Medical Devices·121 affected·Mar 24, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002
Medical Devices·1,483 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000
Medical Devices·69 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Product Code/Part #...
Medical Devices·40,166 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002
Medical Devices·217 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74CX-B; 5) 74ME-B...
Medical Devices·70,627 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Aneroid Gauge Sets w...
Medical Devices·385,920 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012
Medical Devices·1 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff Kits, Product Co...
Medical Devices·76,407 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200
Medical Devices·383 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002
Medical Devices·815 affected·Mar 21, 2025
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6; 5) 44WT-B; ...
Medical Devices·34,187 affected·Mar 21, 2025
CriticalFDA
Ge Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002
Medical Devices·15 affected·Mar 21, 2025