FDA (Device enforcement)

11,102 recalls · page 61 of 112

• Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.2023-09-25
• CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C20402023-09-23
• SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V20372023-09-23
• Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.2023-09-22
• 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System2023-09-21
• 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion Pump System2023-09-21
• TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC00052023-09-21
• CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system2023-09-21
• DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.2023-09-21
• DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.2023-09-21
• DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.2023-09-21
• DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.2023-09-21
• DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.2023-09-21
• EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.2023-09-21
• ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system2023-09-21
• Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit2023-09-21
• Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack2023-09-20
• Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack2023-09-20
• Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack2023-09-20
• Monoject 20 mL Syringe Luer-Lock Tip Soft Pack2023-09-20
• Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack2023-09-20
• Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack2023-09-20
• LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.2023-09-19
• NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field case. Eye-tracking headset system is intended for recording, viewing, and analyzing eye movements in su2023-09-19
• DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit2023-09-18
• Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. (1) PN 57400 Stat Profile Prime Plus Analyzer (2) PN 59508 Stat Profile Prime Plus Analyzer, Remanufactured2023-09-18
• IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.2023-09-18
• Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ; (6)2012-320 DRAIN, OCEAN PEDI 2023-09-18
• Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;2023-09-18
• Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU2023-09-18
• Senhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog Number X9007708), Intelligent Surgical Unit (Catalog Number X9007696), and Cockpit, ISU Configuration (Catalog Number X9007707), Software (SW) version 2.7.4; robotic surgical system2023-09-15
• BD Alaris PCU REF 80152023-09-15
• BD Alaris Syringe Module, REF 81102023-09-15
• Alaris PCA Module 81202023-09-15
• EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation2023-09-14
• Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System2023-09-14
• Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Reconstitution Collars.2023-09-14
• Astral 100 and Astral 150 ventilators2023-09-13
• Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 11801007772023-09-13
• Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach. Product Code: OM-10000Z2023-09-13
• BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.2023-09-13
• DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic2023-09-12
• THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhe2023-09-12
• THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhes2023-09-12
• Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 111052002023-09-12
• ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environment and provides comprehensive image acquisition modes. Material Number: 11108110 (2)Cios Spin- a mobile x-ray system designed to provide x-ray imaging of the anatomical structures of2023-09-12
• VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)2023-09-12
• Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-0052023-09-11
• Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-0052023-09-11
• Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-0102023-09-11
• Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-0152023-09-11
• Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-0052023-09-11
• Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-0052023-09-11
• Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-0102023-09-11
• Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-0052023-09-11
• Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-0102023-09-11
• Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-0152023-09-11
• Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-0102023-09-11
• Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-0152023-09-11
• Centricity Universal Viewer Workflow Manager, Image processing radiological system2023-09-08
• Universal Viewer Workflow Manager, Image processing radiological system2023-09-08
• Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB102992023-09-07
• 2008T Hemodialysis SYS, with CDX2023-09-06
• 2008T Hemodialysis System without CDX2023-09-06
• 2008T Hemodialysis System w/Bibag2023-09-06
• 2008T GEN 2 Bibag without CDX2023-09-06
• 2008T HD SYS. CDX BLUESTAR2023-09-06
• 2008T HD SYS. CDX W/BIBAG BLUESTAR2023-09-06
• 2008T HD SYS. W/O CDX BLUESTAR2023-09-06
• 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR2023-09-06
• Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F22023-09-06
• BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01; Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-012023-09-06
• Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-12023-09-06
• RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number: RX40402023-09-06
• RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)2023-09-06
• RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R (refurbished)2023-09-06
• RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX90002023-09-06
• RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX50002023-09-06
• AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in l2023-09-06
• Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system2023-09-06
• Zimmer Dermatome Blades- 10-pack boxes of blades. Intended for use with the dermatome handpiece which is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities Part number: 008800000102023-09-05
• MAZOR X robotic guidance system, Model TPL0059, with software versions 4.2.2 or 5.0.12023-09-05
• Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.2023-09-05
• General Pack, REF BBGP31C2023-09-01
• LAVH, REF BBLV21C2023-09-01
• Breast Plastics Pack, REF BBPL20D2023-09-01
• CVS PCSU SJH, REF SJCV48J2023-09-01
• Pediatric Heart SJH, REF SJPH34K2023-09-01
• Vasc. Open CVOR SJH, REF SJVO56B2023-09-01
• Robotics Pack, REF SJVO56B2023-09-01
• Robotics Pack, REF SSRO22D2023-09-01
• Sub Q Recorder Pack, REF BPRC87A2023-09-01
• Pediatric Urology Wolson Pack, REF BPPU55A2023-09-01
• Cath Cardiac Pack, REF IHCC03V2023-09-01
• Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked2023-09-01
• (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM Mica MAGNETOM Spectra Siemens Model Number:11060845 Used with the following MAGNETOM MRI Systems: MAGENTOM Amira 10836777 & 10838610; MAGENTOM Free.Max 11408424 & 11408425; MAGNETOM F2023-09-01
• HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 800020022023-08-31
• HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 800020042023-08-31
• EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultaneously, Product Code 8633802023-08-31
• 4500MD Triple Quad Mass Spectrometer, Part Number 50325222023-08-30