FDA (Device enforcement)

11,102 recalls · page 26 of 112

• Model Number 40KWFXPLUS.005, Mobile X-ray system2025-06-10
• Model Number 40KWFXPLUS-710CW, Mobile X-ray system2025-06-10
• Model Number 40KWFXPLUS-710CW.007, Mobile X-ray system2025-06-10
• Model SM-32HF-Batt; 32KW ANALOG, Mobile X-ray system2025-06-10
• Model SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray system2025-06-10
• Model Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray system2025-06-10
• Model SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system2025-06-10
• Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray system2025-06-10
• Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray system2025-06-10
• Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray system2025-06-10
• Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray system2025-06-10
• Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system2025-06-10
• Model Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray system2025-06-10
• Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray system2025-06-10
• Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray system2025-06-10
• Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray system2025-06-10
• Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray system2025-06-10
• Model Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray system2025-06-10
• RADPRO MOBILE, Mobile X-ray system2025-06-10
• SM_40HF_B_D_VIR3, Mobile X-ray system2025-06-10
• VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE 63CM/45DEG/D0) VXSK0121 VXSK (180P RF WIRE 63CM/45DEG/D1) VXSK0122 VXSK (180P RF WIRE 63C2025-06-10
• VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.2025-06-10
• VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transse2025-06-10
• Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation /2025-06-10
• Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/3502025-06-10
• Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4602025-06-10
• VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);2025-06-10
• VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);2025-06-10
• BostonSight SCLERAL Lens2025-06-10
• BostonSight PROSE Lens.2025-06-10
• Akreos, SKU: AO60P0300. Akreos intraocular lenses2025-06-06
• Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion Indirect Decompression System 14MM,2025-06-06
• Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous access device supplied Sterile and single use. Indicated for Intra-osseous access to the Proximal humerus a2025-06-05
• Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous access device supplied Sterile and single use. Indicated for Intraosseous access to the Proximal humerus and 2025-06-05
• High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/C2025-06-05
• Custom Tubing Kit: REF: K04-00417, K04-00963, K04-010292025-06-05
• Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B2025-06-05
• Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP2025-06-05
• UROSKOP Omnia Max. Model Number: 107624732025-06-04
• ADVIA¿ 120/2120/2120i SETpoint Calibrator2025-06-04
• ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)2025-06-04
• ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)2025-06-04
• ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)2025-06-04
• Azurion 7 M20. Fluoroscopic X-Ray System.2025-06-04
• Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA2025-06-04
• Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-102025-06-04
• Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)2025-06-03
• BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 211202025-06-03
• BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 0213162025-06-03
• REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra2025-06-03
• REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.2025-06-03
• REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.2025-06-03
• SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-20002025-06-03
• Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.2025-06-03
• Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for us2025-06-02
• Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for us2025-06-02
• Medshape Universal Joints, REF: DNE-9000-UJ2025-06-02
• Servo-u Ventilator System. Model Number: 6688600.2025-05-30
• Servo-n Ventilator System. Model Number: 6694800.2025-05-30
• Servo-u MR Ventilator System. Model Number: 6888800.2025-05-30
• Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044; 3) Viking XL Mobile lift - Product Code 2040043; 4) Viking M Mobile lift - Product Code 2040045A; 5) Viki2025-05-30
• Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R2025-05-30
• Spectral CT. Computed tomography X-ray system.2025-05-29
• LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S4002025-05-29
• Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: All software versions;2025-05-28
• Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indicati2025-05-28
• Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm Model/Catalog Number: 506-04-122 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indicati2025-05-28
• Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indicati2025-05-28
• Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm Model/Catalog Number: 506-04-130 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indicati2025-05-28
• CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit2025-05-28
• Philips 3D9-3v Transducer.2025-05-28
• Philips C5-1 Transducer.2025-05-28
• Philips C5-2 Transducer.2025-05-28
• Philips C9-5EC Transducer.2025-05-28
• Philips eL18-4 Transducer.2025-05-28
• Philips eL18-4 EMT Transducer.2025-05-28
• Philips L12-3 Transducer.2025-05-28
• Philips L12-4 Transducer.2025-05-28
• Philips L8-4 Transducer.2025-05-28
• Philips L9-3 Transducer.2025-05-28
• Philips S5-1 Transducer.2025-05-28
• Philips S7-2 Transducer.2025-05-28
• Philips S7-3t Transducer.2025-05-28
• Philips S8-3t Transducer.2025-05-28
• Philips V6-2 Transducer.2025-05-28
• Philips VL13-5 Transducer.2025-05-28
• Philips X5-1 Transducer.2025-05-28
• Philips X6-1 Transducer.2025-05-28
• Philips X7-2t Transducer.2025-05-28
• Philips X8-2t Transducer.2025-05-28
• Philips XL14-3 Transducer.2025-05-28
• KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 124932025-05-27
• Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H2025-05-23
• EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous2025-05-23
• MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line for use with the Integra Flow Source for the controlled application of two liquids.2025-05-23
• Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product Description: The Omnipod 5 iOS App software is available to download through the Apple app store. The Omnipod 5 App is the user interface that controls the Omnipod 5 Automat2025-05-23
• Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC2025-05-23
• Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC0106652025-05-23
• Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B2025-05-23
• SIGNA Architect2025-05-23