FDA (Device enforcement)

11,102 recalls · page 27 of 112

• SIGNA Architect AIR2025-05-23
• Discovery MR750w 3.0T2025-05-23
• SIGNA PET/MR2025-05-23
• Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S.2025-05-22
• Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S.2025-05-22
• Extended Tip Applicator, 8CM, Box of 5.2025-05-22
• Extended Tip Applicator, 15 CM, Box of 5.2025-05-22
• Extended Tip Applicator 8CM, Box of 1.2025-05-22
• Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;2025-05-22
• Change Healthcare Cardiology Hemo Software2025-05-22
• Change Healthcare Cardiology Hemodynamics Software2025-05-22
• IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; IontoPatch is an Iontophoresis transdermal patch.2025-05-22
• IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.2025-05-22
• Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-UK, HT70PM-WW-EU, HT70P2025-05-21
• STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.2025-05-21
• Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Actin2025-05-21
• LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.2025-05-21
• REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY2025-05-21
• REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood Control Technology, 20GA x 1.00 in (1.1x25 mm) 63 mL/min, STERILEEO, RxOnly2025-05-21
• REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly2025-05-21
• REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25 mm) 65 mL/min, STERILEEO, RxOnly2025-05-21
• REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly2025-05-21
• REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly2025-05-21
• REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly2025-05-21
• REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly2025-05-21
• REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly2025-05-21
• BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to pyrazinamide (PZA).2025-05-20
• Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via 2025-05-16
• GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system2025-05-16
• GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP2025-05-16
• Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coating. Refer to the pro2025-05-15
• Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.2025-05-15
• Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hou2025-05-14
• Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hou2025-05-14
• Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No2025-05-14
• Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No2025-05-14
• Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No2025-05-14
• Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No2025-05-14
• Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 7821462025-05-13
• Product Name: SmartPath to dStream for 3.0T; Model Number: 7821452025-05-13
• Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;2025-05-13
• Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;2025-05-13
• Product Name: Upgrade to MR 7700; Model Number: 782130;2025-05-13
• Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;2025-05-13
• Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;2025-05-13
• Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;2025-05-13
• Product Name: Ingenia 1.5T S; Model Number: 781347;2025-05-13
• Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;2025-05-13
• Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;2025-05-13
• Product Name: Ingenia 1.5T CX; Model Number: 781262;2025-05-13
• Product Name: Ingenia 3.0T CX; Model Number: 781271;2025-05-13
• Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;2025-05-13
• Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;2025-05-13
• Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;2025-05-13
• Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;2025-05-13
• Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;2025-05-13
• Allon 2001. Part Number: 200-002632025-05-13
• IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.2025-05-12
• Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)2025-05-12
• Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113 (MT26403-3)2025-05-12
• Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)2025-05-12
• Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)2025-05-12
• Baxter Novum IQ Syringe Pump, product code 40800BAXUS,2025-05-12
• Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE Lined2025-05-12
• BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY80602025-05-12
• BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-00062025-05-12
• BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-05002025-05-12
• BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241; BD TEXIUM (China), REF: 10012241 CHINA2025-05-12
• The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 (or DM) Analyzer with plasma conversion that multiplies the measured whole blood glucose value by a factor of 1.112 and displays a plasma equivalent glucose result. HemoCue Glucose 201 Microcuvettes are available2025-05-12
• da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-152025-05-12
• Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR sys2025-05-09
• BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.2025-05-09
• BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.2025-05-09
• BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS2025-05-09
• Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 68029152025-05-09
• Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.2025-05-09
• Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.2025-05-09
• Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 00818053026614 OPTI0152HSS10 0082025-05-08
• Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 00810068567373 PRES0204CXPPLT 008102025-05-08
• Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main 10885403512629 [303], BD Pyxis MedStation ES Tower 10885403512674 [352], BD Pyxis Anesthesia Station ES 10885403477836 [327], BD Pyxis MedStation ES (Main) 10885403512667 2025-05-08
• BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323 BD Pyxis" CII Safe ES / 10885402025-05-08
• Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.2025-05-07
• Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.2025-05-07
• Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.2025-05-07
• Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM00002 OBM DAB (Digital Acquisition Box) Model/Catalog Number: OBM00002 OBM DAB (Digital Acquisition Box) Software Version: N/A Product Description: OBM00002 OBM DAB (Digital Acquisition Box) Component: No2025-05-07
• Brand Name: SmartRelease ESTR (Endoscopic soft tissue release system), Onyx Blade Assembly; alternate name: ECTR (Endoscopic Carpal Tunnel Release) System, Onyx Blade Assembly; Common Name: SmartRelease Onyx; Catalog (SKU) Numbers: 83030-1 (single pack), 83030-6 (six pack) and 83030-6-CE (six pack O2025-05-07
• DxI 9000 Access Immunoassay Analyzer C111372025-05-07
• Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E100436, P3700E100437, P3700E100438, P3700E100439, P3700E100441, P3700E100442, P3700E100443, P3700E100444, P3700E100445, P3700E100446, P3700E100448, P3700E100449, P3700E100450, P3700E1002025-05-06
• Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential so2025-05-06
• Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureterosco2025-05-06
• Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TLF-FBX940S, TFL-FBX150BS-JA (Japan Only), TFL-FBX550S-JA (Japan Only), TFL-FBX940S-JA (Jap2025-05-06
• Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-JA (Japan Only), TFL-FB2025-05-06
• SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Purple, Model: 07 6011; SAFE-T-FILL Micro Capillary Blood Collection, 125 ¿L Prepared with Dipotassium EDTA Self-sealing Cap, Purple, Model: 07 6013; SAFE-T-FILL Micro Capillary Blood Collection, 200 ¿L Prepared with2025-05-05
• Access Testosterone assay, Catalog Number 335602025-05-05
• Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system2025-05-05
• Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V2025-05-05
• LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.22025-05-02
• Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs2025-05-02
• Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen2025-05-02
• Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen2025-05-02