FDA (Device enforcement)

11,102 recalls · page 22 of 112

• Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;2025-09-03
• Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;2025-09-03
• Allura Xper FD20/20 OR Table; Product Code: 722039; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;2025-09-03
• Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;2025-09-03
• Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;2025-09-03
• Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;2025-09-03
• Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;2025-09-02
• Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumati2025-09-02
• Getinge 88-Series Washer- Disinfector. Model Number: 88-5.2025-08-29
• NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cleared for marketing in the 2025-08-29
• ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.2025-08-29
• Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM2025-08-29
• CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C84192025-08-29
• CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C85192025-08-29
• CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C85372025-08-29
• CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C85412025-08-29
• Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose 2025-08-28
• Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)2025-08-28
• Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);2025-08-28
• 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;2025-08-28
• Biograph mMR. Model Number: 10433372.2025-08-28
• BIOGRAPH One (DE). Model Number: 11689172.2025-08-28
• MAGNETOM Cima.X (DE). Model Number: 11647158.2025-08-28
• MAGNETOM Lumina (DE). Model Number: 11344916.2025-08-28
• MAGNETOM Prisma. Model Number: 10849582.2025-08-28
• MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.2025-08-28
• MAGNETOM Skyra fit. Model Number: 10849580.2025-08-28
• MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.2025-08-28
• MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.2025-08-28
• MAGNETOM Verio Dot. Model Number: 10684333.2025-08-28
• MAGNETOM Verio Dot Upgrade. Model Number: 10684334.2025-08-28
• MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.2025-08-28
• MAGNETOM Vida Fit. Model Number: 11410481.2025-08-28
• GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.2025-08-26
• Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.2025-08-26
• Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.2025-08-26
• Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.2025-08-26
• Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a conduit for hemodialysis.2025-08-25
• MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Number 2030360-001, Product Codes VU2 and VU42025-08-22
• Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically con2025-08-21
• Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q2025-08-21
• ACCOLADE SR SL (Model L300)2025-08-20
• ACCOLADE DR SL (Model L301)2025-08-20
• ACCOLADE SR SL MRI (Model L310)2025-08-20
• ACCOLADE DR SL MRI (Model L311)2025-08-20
• ACCOLADE DR EL (Model L321)2025-08-20
• ACCOLADE DR EL MRI (Model L331)2025-08-20
• PROPONENT SR SL (Model L200)2025-08-20
• PROPONENT DR SL (Model L201)2025-08-20
• Model Number L209 PROPONENT DR (VDD) SL Pacemaker2025-08-20
• Model Number L210 PROPONENT SR SL Pacemaker2025-08-20
• Model Number L211 PROPONENT DR SL MRI Pacemaker2025-08-20
• Model Number L221 PROPONENT DR EL Pacemaker2025-08-20
• Model Number L231, PROPONENT DR EL MRI Pacemaker2025-08-20
• Model Number L100, ESSENTIO SR SL Pacemaker2025-08-20
• Model Number L101, ESSENTIO DR SL Pacemaker2025-08-20
• Model Number L110, ESSENTIO SR SL MRI Pacemaker2025-08-20
• Model Number L111, ESSENTIO DR SL MRI Pacemaker2025-08-20
• Model Number L121 ESSENTIO DR EL Pacemaker2025-08-20
• Model Number L131, ESSENTIO DR EL MRI Pacemaker2025-08-20
• Model Number S701 ALTRUA 2 SR SL Pacemaker2025-08-20
• Model Number S702, ALTRUA 2 DR SL Pacemaker2025-08-20
• Model Number S722, ALTRUA 2 DR EL Pacemaker2025-08-20
• Model Number U125, VALITUDE CRT-P EL2025-08-20
• Model Number U128, VALITUDE CRT-P EL MRI2025-08-20
• Model Number U225 VISIONIST CRT-P EL2025-08-20
• Model Number U226, VISIONIST CRT-P EL2025-08-20
• Model Number U228, VISIONIST CRT-P EL MRI2025-08-20
• Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Packaged, CA; Product Code: 00422025-08-20
• Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Description: Greiner VACUETTE Blood Collection Tube with Clot Activator and Gel Separator and Standard Stopper (16 x 100 mm, 8ml)2025-08-19
• AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.2025-08-18
• AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.2025-08-18
• ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H7493961180002025-08-18
• Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/2025-08-15
• Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)2025-08-15
• Heartstring III Proximal Seal System. Intravascular anastomosis occluder.2025-08-15
• Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.2025-08-15
• Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.2025-08-15
• BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E2025-08-15
• Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X2025-08-13
• Penner Pacific Bathing Spa, Model Numbers 360010-2WT, 360010-1, 370000-1W, 360010-1WT, 362010-1, 370000-1WL, 360010-1L, 360010-1W, 360010-XWTL, 370000-XWL, 360010-1WTL, 360010-XWT, 360010-2, 370000-2W, 360010-2L, 370000-2WL, 360010-X, 370000-XW, 360010-2W, 362010-2, 360010, 37000-XWL, 362010-X, 36202025-08-13
• Penner Pacific Bathing Spa, Model Numbers 360020-1P2025-08-13
• Penner Pacific Bathing Spa, Model Numbers 360030-1C, 360030-1CE, 360030-1CTS, 360030-XCE, 360030-XC, 360030-1CT, 360030-1C, 360030-XC, 360030-XCT, 360030-1CTS, 360030-XCTS, 3600301-CTS, 360030-XCE, 360030-1CT, 360030-1CE, 36030-XCT2025-08-13
• Penner Pacific Bathing Spa, Model Numbers 361910-1A, 361910-1A, 361910-XA, 361910-2I, 361910-1A, 361910-1, 361910-XI, 361910-1I, 361910-2A, 36191-1A, 361910-X2025-08-13
• Penner Pacific Bathing Spa, Model Numbers 390010-1, 390010-X, 390010-22025-08-13
• Penner Pacific Bathing Spa, Model Numbers 760010-1, 770010-12025-08-13
• Penner Pacific Bathing Spa, Model Numbers 860010-1L2025-08-13
• UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C114782025-08-13
• UniCel DxH 690T COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C345202025-08-13
• UniCel DxH 800 COULTER Cellular Analysis System, configured with the Led HGB Photometer REFs:B24802, 629029, B633222025-08-13
• UniCel DxH 600 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF:B238582025-08-13
• Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.2025-08-13
• Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.2025-08-13
• Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.2025-08-13
• Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.2025-08-13
• Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.2025-08-13
• Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.2025-08-13
• NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adul2025-08-12
• NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 90, REF E NRT-05090-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adul2025-08-12
• NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 8 F x 55, REF E NRT-06055-I The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adul2025-08-12