Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I; 2) ARTHROSCOPY PACK-LF, Pack Number DYNJ0390808F; ...
Medical Devices·186 affected·Feb 11, 2025
High RiskFDA
Immuno-mycologics, Inc
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates ...
Medical Devices·30 affected·Feb 10, 2025
High RiskFDA
Brainlab Ag
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Medical Devices·0 affected·Feb 10, 2025
High RiskFDA
American Contract Systems Inc
MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02
Medical Devices·147 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
LABOR & DELIVERY PACK, Model Nos LLLD19H
Medical Devices·725 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
Medical Devices·1,420 affected·Feb 6, 2025
High RiskFDA
Integra Lifesciences Corp.
AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catal...
Medical Devices·623 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Medical Devices·534 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
Medical Devices·252 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
DELIVERY PACK , Model No SGDV22D-01 SGDV22E
Medical Devices·36 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
Medical Devices·388 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
Medical Devices·690 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
Medical Devices·237 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
CYSTO , Model No SACY80R
Medical Devices·144 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
Medical Devices·1,200 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
Medical Devices·1,836 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
Medical Devices·48 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
CYSTO PACK , Model N. HKCY31A
Medical Devices·36 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
BORN ON ARRIVAL KIT , Model No LLBN11B
Medical Devices·54 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
Medical Devices·41 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
Medical Devices·956 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
Medical Devices·1,106 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
AV FISTULA , Model No UTAV77T
Medical Devices·90 affected·Feb 6, 2025
High RiskFDA
American Contract Systems Inc
THORACIC PACK , Model No UTTC82Y UTTC82AA-01
Medical Devices·40 affected·Feb 6, 2025
CriticalFDA
Medtronic Perfusion Systems
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR FLOWGUARD 14GA...
Medical Devices·316,205 affected·Feb 5, 2025
CriticalFDA
Bard Peripheral Vascular Inc
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 8...
Medical Devices·15,755 affected·Feb 5, 2025
High RiskFDA
Medical Information Technology, Inc.
MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for ...
Medical Devices·148 affected·Feb 5, 2025
High RiskFDA
American Contract Systems Inc
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Medical Devices·91 affected·Feb 4, 2025
High RiskFDA
Medimaps Group
Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1....
Medical Devices·2,036 affected·Feb 3, 2025
High RiskFDA
Instrumentation Laboratory
HemosIL LMW Heparin Controls; Part Number: 0020300200;
Medical Devices·41,824 affected·Feb 3, 2025
High RiskFDA
Ge Healthcare (china) Co., Ltd.
Brivo MR355, NMRI system
Medical Devices·22 affected·Jan 31, 2025
High RiskFDA
Ge Healthcare (china) Co., Ltd.
SIGNA Creator, SIGNA Explorer, NMRI systems
Medical Devices·2,538 affected·Jan 31, 2025
High RiskFDA
Ge Healthcare (china) Co., Ltd.
SIGNA MR355, SIGNA MR360, NMRI system
Medical Devices·241 affected·Jan 31, 2025
High RiskFDA
American Contract Systems, Inc.
Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Compone...
Medical Devices·800 affected·Jan 31, 2025
CriticalFDA
Medtronic Minimed, Inc.
Paradigm REF: MMT-712 and MMT-715
Medical Devices·20,760 affected·Jan 31, 2025
CriticalFDA
Micro Therapeutics, Inc.
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-2...
Medical Devices·7,820 affected·Jan 30, 2025
High RiskFDA
Leica Biosystems Nussloch Gmbh
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
Medical Devices·2 affected·Jan 30, 2025
CriticalFDA
Micro Therapeutics, Inc.
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-3...
Medical Devices·18,245 affected·Jan 30, 2025
High RiskFDA
Stryker Corporation
Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197
Medical Devices·9,521 affected·Jan 29, 2025
High RiskFDA
Pentax Of America Inc
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic ...
Medical Devices·94 affected·Jan 29, 2025
High RiskFDA
Pentax Of America Inc
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the low...
Medical Devices·138 affected·Jan 29, 2025
High RiskFDA
Ge Medical Systems, Llc
Optima XR646 HD. X-Ray imaging system.
Medical Devices·3,149 affected·Jan 28, 2025
High RiskFDA
Ge Medical Systems, Llc
Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.
Medical Devices·3,149 affected·Jan 28, 2025
High RiskFDA
Ge Medical Systems, Llc
Discovery XR656 HD. X-Ray imaging system.
Medical Devices·3,149 affected·Jan 28, 2025
High RiskFDA
Merit Medical Systems, Inc.
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Medical Devices·40 affected·Jan 27, 2025
High RiskFDA
Guangzhou Pluslife Biotech Co., Ltd.
Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Versi...
Medical Devices·1,850 affected·Jan 24, 2025
High RiskFDA
Guangzhou Pluslife Biotech Co., Ltd.
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product D...
Medical Devices·541 affected·Jan 24, 2025
High RiskFDA
Carefusion 303, Inc.
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the ...
Medical Devices·242,098 affected·Jan 23, 2025