FDA (Device enforcement)

11,102 recalls · page 25 of 112

• Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;2025-06-30
• Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;2025-06-30
• Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;2025-06-30
• Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;2025-06-30
• Ingenia 1.5T S Model Number (REF): 781347;2025-06-30
• Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;2025-06-30
• Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;2025-06-30
• Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;2025-06-30
• Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;2025-06-30
• Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);2025-06-30
• Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);2025-06-30
• MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;2025-06-30
• MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;2025-06-30
• SmartPath to dStream for 3.0T Model Number (REF): 782145;2025-06-30
• SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;2025-06-30
• SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;2025-06-30
• Upgrade to MR 7700 Model Number (REF): 782130;2025-06-30
• DreamStation Auto CPAP. Non-Continuous Ventilator.2025-06-30
• DreamStation Auto BiPAP. Non-Continuous Ventilator.2025-06-30
• DreamStation Auto. Non-Continuous Ventilator.2025-06-30
• Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.2025-06-27
• LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)2025-06-27
• LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894L2025-06-27
• Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile2025-06-27
• Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.2025-06-26
• RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.2025-06-26
• UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,2025-06-26
• UniCel DxI 800 Access Immunoassay Analyzer, Part Number 9731002025-06-25
• DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A714572025-06-25
• DxI 800 Access Immunoassay Analyzer W/Spot B, Part Number A714562025-06-25
• UniCel DxI 600 Access Immunoassay Analyzer, Part Number A302602025-06-25
• DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A714612025-06-25
• DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A714602025-06-25
• 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 Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.2025-06-25
• FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M4012025-06-25
• NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 90006622025-06-25
• LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.2025-06-24
• Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941-SG, DS10005941, 10005941J, 10005941JP, 10005941JPN2025-06-23
• Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Im2025-06-23
• Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems2025-06-23
• Dual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems2025-06-23
• Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeu2025-06-23
• Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to 2025-06-23
• Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX22025-06-20
• One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.2025-06-20
• One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.2025-06-20
• GE Signa Artist, Nuclear Magnetic Resonance Imaging System2025-06-20
• GE Signa Voyager, Nuclear Magnetic Resonance Imaging System2025-06-20
• GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System2025-06-20
• GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System2025-06-20
• GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System2025-06-20
• GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System2025-06-20
• GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System2025-06-20
• GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System2025-06-20
• GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance2025-06-20
• GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System2025-06-20
• GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System2025-06-20
• M5 Corpus Power Wheelchair REF,1200322025-06-19
• Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard electroencephalograph2025-06-18
• Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia2025-06-18
• Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia A2025-06-18
• Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip2025-06-18
• Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip2025-06-18
• Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver All2025-06-18
• KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805L2025-06-17
• Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software Model 2025-06-17
• Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara application, Software Model Number D00U004; 3. Cobalt Crome application, Software2025-06-17
• QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SC2025-06-17
• SafeStar 90 Plus Filter. Bidirectionally breathing system filter.2025-06-16
• SafeStar 55 Plus Filter. Bidirectionally breathing system filter.2025-06-16
• HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.2025-06-16
• SafeStar 60A Plus Filter. Bidirectionally breathing system filter.2025-06-16
• SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE0103012025-06-16
• BD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF: 515003 BD PhaSeal Injector Luer Lock (N35C), REF: 515004 BD PhaSeal Injector Lu63er Lock (N35C Multi), REF: 515005 BD PhaSeal Protector (P14), REF: 515100 BD PhaSeal Protector (P21), REF: 515102 BD PhaSeal Protect2025-06-16
• Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.2025-06-13
• VITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.2025-06-12
• Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm femoral heads and all hip stem2025-06-12
• Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Model/Catalog Number: 952-28-42F Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular¿ system, 28mm femoral heads and all hip stem2025-06-12
• Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.2025-06-12
• Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT, REF DYKM15642025-06-12
• Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P2025-06-12
• Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.2025-06-12
• Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP, REF DYNJ32702B2025-06-12
• Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-12502025-06-12
• ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL2025-06-12
• Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.2025-06-12
• Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)2025-06-11
• HSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in hysterosalpingography and sonohysterography procedures.2025-06-11
• Endosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience Kit2025-06-11
• Endosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System Convenience Kit with IV Tube.2025-06-11
• ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).2025-06-11
• DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.2025-06-11
• GENERAL LAPAROSCOPY TRAY. Medical convenience kit.2025-06-11
• GS ENDOSCOPY PACK. Medical convenience kit.2025-06-11
• GYN LAPAROSCOPY PACK. Medical convenience kit.2025-06-11
• Sedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)2025-06-10
• MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system2025-06-10
• Model Number 40KWFX, Mobile X-ray system2025-06-10
• Model Number 40KWFXPLUS, Mobile X-ray system2025-06-10
• Model Number 40KWFXPLUS.002, Mobile X-ray system2025-06-10