Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Nuclein Llc
DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B T...
Medical Devices·710 affected·Jun 25, 2025
High RiskFDA
Fresenius Kabi Usa, Llc
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Medical Devices·348,150 affected·Jun 24, 2025
High RiskFDA
Orthofix U.s. Llc
PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP
Medical Devices·3 affected·Jun 24, 2025
High RiskFDA
Fresenius Kabi Usa, Llc
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Medical Devices·19,225 affected·Jun 24, 2025
High RiskFDA
Ge Medical Systems, Llc
GE Signa Artist, Nuclear Magnetic Resonance Imaging System
Medical Devices·760 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System
Medical Devices·0 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System
Medical Devices·2 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE Signa Voyager, Nuclear Magnetic Resonance Imaging System
Medical Devices·280 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System
Medical Devices·330 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System
Medical Devices·19 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System
Medical Devices·0 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System
Medical Devices·138 affected·Jun 20, 2025
CriticalFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Medical Devices·14 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System
Medical Devices·0 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance
Medical Devices·97 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System
Medical Devices·0 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System
Medical Devices·0 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System
Medical Devices·0 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System
Medical Devices·0 affected·Jun 20, 2025
High RiskFDA
Ge Medical Systems, Llc
GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System
Medical Devices·151 affected·Jun 20, 2025
CriticalFDA
Baxter Healthcare Corporation
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Medical Devices·28 affected·Jun 20, 2025
High RiskFDA
Medtronic, Inc.
Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application...
Medical Devices·22,091 affected·Jun 18, 2025
High RiskFDA
Stryker Corporation
Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
Medical Devices·0 affected·Jun 18, 2025
High RiskFDA
Olympus Corporation Of The Americas
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resec...
Medical Devices·11 affected·Jun 18, 2025
High RiskFDA
Olympus Corporation Of The Americas
Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with G...
Medical Devices·1 affected·Jun 18, 2025
High RiskFDA
Medtronic, Inc.
Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, ...
Medical Devices·22,091 affected·Jun 18, 2025
High RiskFDA
Olympus Corporation Of The Americas
Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatibl...
Medical Devices·2 affected·Jun 18, 2025
High RiskFDA
Natus Neurology Dba Excel Tech., Ltd. (xltek)
Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph
Medical Devices·27 affected·Jun 18, 2025
High RiskFDA
Olympus Corporation Of The Americas
Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI El...
Medical Devices·16 affected·Jun 18, 2025
High RiskFDA
Olympus Corporation Of The Americas
Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI El...
Medical Devices·48 affected·Jun 18, 2025
High RiskFDA
Medtronic, Inc.
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azur...
Medical Devices·3,909 affected·Jun 17, 2025
CriticalFDA
Intersurgical Inc
i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is indicated to facilitate laryngoscopy.
Medical Devices·2,152 affected·Jun 17, 2025
High RiskFDA
Quidel Corporation
QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC
Medical Devices·22,470 affected·Jun 17, 2025
High RiskFDA
Medtronic, Inc.
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: ...
Medical Devices·5,418 affected·Jun 17, 2025
CriticalFDA
Draeger, Inc.
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Medical Devices·669,838 affected·Jun 16, 2025
High RiskFDA
Coopervision, Inc.
Biofinity XR Toric Contact Lens
Medical Devices·397 affected·Jun 16, 2025
High RiskFDA
Medtronic Minimed, Inc.
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Medical Devices·6,816 affected·Jun 16, 2025
CriticalFDA
Draeger, Inc.
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Medical Devices·9,885,139 affected·Jun 16, 2025
CriticalFDA
Draeger, Inc.
SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
Medical Devices·374,700 affected·Jun 16, 2025
High RiskFDA
Bd Switzerland Sarl
BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF...
Medical Devices·3,884,670 affected·Jun 16, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOO...
Medical Devices·15,700 affected·Jun 12, 2025
High RiskFDA
Beckman Coulter Inc.
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
Medical Devices·496 affected·Jun 12, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
Medical Devices·184 affected·Jun 12, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B
Medical Devices·48 affected·Jun 12, 2025
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM1564
Medical Devices·960 affected·Jun 12, 2025
High RiskFDA
Bridge To Life Ltd
Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number R...
Medical Devices·4,528 affected·Jun 12, 2025
High RiskFDA
Avid Medical, Inc.
GYN ROBOTIC PACK. Medical convenience kit.
Medical Devices·45 affected·Jun 11, 2025
High RiskFDA
Avid Medical, Inc.
LAP CHOLE PACK. Medical convenience kit.
Medical Devices·85 affected·Jun 11, 2025