FDA (Device enforcement)

11,102 recalls · page 81 of 112

• Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005. b. SKIN MARKER MAMMO BB2.0 100B - Mammography Skin Marker Catalog # SDM-BB20.2022-05-25
• Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/2"X5YDSSTR LF (12/CS) MGM61 Catalog #61-59220. c. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1"X5YDS STR LF (12/2022-05-25
• a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AG2X2" (10/BX 10BX/CS) Catalog #3557. c. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGSHEET 4"X4.75" (10/2022-05-25
• a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHIGH-ABSRB 4"X4 3/4" (10/BX) Catalog #87400. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WND GELLING FIBER HIABSRB AG 4X4.75 (10/BX 10BX/CS Catalog #177400. c. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, WOUND GELLING FIBERHI2022-05-25
• 3M SYSTAGENIX/KCI KerraCel Ag DRESSING, WOUND KERRACEL AG 4X5 (10/CT 10CT/CS) Catalog #CWL11582022-05-25
• Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System2022-05-24
• Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.2022-05-24
• Endo Model Modular Femur and Tibia, PorEx. orthopedic prosthesis. Model Nos.: X-Small, Right 15-3815/11, Small, Right 15-3816/11, Small, Left 15-3816/12, Medium, Right 15-3817/11, Medium, Left 15-3817/12, Large, Right 15-3818/11.2022-05-24
• Tibial Component. orthopedic prosthesis. Model Nos: Small, W 16-2817/02 Medium, W 16-2817/05 Large, W 16-2817/072022-05-24
• Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/372022-05-24
• t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump with the Control-IQ Technology2022-05-24
• MiniMed 630G Insulin Pump (U.S. and Canada Version)2022-05-23
• MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)2022-05-23
• MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)2022-05-23
• Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 113276002022-05-20
• CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 79000012022-05-20
• Sensica Urine Output System2022-05-19
• ABL800 Flex Analyzer Model Numbers 393-800 and 393-8012022-05-18
• #1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED2022-05-17
• Drager SafeStar 55, Catalog No. MP017902022-05-16
• NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Model No. 3009002022-05-13
• Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile EO, CE 27972022-05-13
• Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile EO, CE 27972022-05-13
• EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.2022-05-13
• RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer carton labeled as Rayner RayOne EMV US, REF RAO200E, SE: +19.00D, Sph: +19.00D; and (2) Inner primary device packaging labeled as Rayner RayOne EMV US, REF RAO200E, SE: +22022-05-13
• Alcon Clareon IOL with AutonoMe Delivery System2022-05-11
• Medline Pill Splitters; 1 each/box; 144 boxes/carton2022-05-11
• CARESCAPE Central Station (CSCS) V2, Model numbers 2082278-001 and 2082279-001. Update 3/10/2023: The following FRU and display part numbers have been added as affected devices: (1) Part #2082294-001, FRU MP200 POWER SUPPLY ASSEMBLY; (2) Part #2082293-002-R, FRU MP200 CPU ASSEMBLY; (3) Part #20822932022-05-10
• BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)2022-05-09
• BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)2022-05-09
• BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)2022-05-09
• BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)2022-05-09
• BD Connecta Stopcock Without Extension Tube Catalog No. 394605 (OUS)2022-05-09
• BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)2022-05-09
• BD Connecta" Plus1 360 Blue Blend Catalog No. 394911 (OUS)2022-05-09
• BD Connecta White 360 Shelf 100Ea Catalog No. 395000 (OUS)2022-05-09
• Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)2022-05-09
• Nexiva with Single BD Connecta Stopcock Version (20 Ga Blue) Catalog No.383682 (OUS)2022-05-09
• VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF ARDVST229036A VST66SF ARDV2022-05-06
• Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)2022-05-05
• Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342 MWCE-18-7-8-NESTER G52739 MWCE-18-7-5-NESTER G23521 MWCE-18-3-3-NEST2022-05-05
• Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-18S-4/2-TORNADO-081800 G13103 MWCE-18S-4/2-TORNADO G08357 MWCE-18S-5/2-TOR2022-05-05
• HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.2022-05-05
• Arrow Three-Lumen CVC2022-05-05
• NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.22022-05-03
• NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.22022-05-03
• STORZ KARL STORZ-ENDOSKOPE REF 11272VUE CMOS Video Cysto-Urethroscope REF 11272VUEK CMOS Video Cysto-Urethroscope C-VIEW KIT REF 11272VUE-R CMOS Video Cysto-Urethroscope REF 11272VUEK-R CMOS Video Cysto-Urethroscope C-VIEW KIT2022-05-03
• Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm2022-05-03
• illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model: MiSeq Dx illumina REF 20014053 Model: MiSeq Dx2022-05-03
• illumina Model NextSeq 550 Dx REF 200057152022-05-03
• System: Alphenix 4D CT in combination with CAS-930A (C arm Support) Model Number: INFX-8000C/BF, INFX-8000C/BH, INFX-8000C/SW2022-05-03
• Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 68877002022-05-02
• Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 68879002022-05-02
• NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 82295062022-04-29
• NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 82293062022-04-29
• NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J2022-04-29
• Centricity Universal Viewer Zero Footprint Client2022-04-28
• Centricity Radiology RA6002022-04-28
• Centricity Cardiology CA10002022-04-28
• Centricity PACS RA10002022-04-28
• Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)2022-04-28
• In-Line ventilator adaptor2022-04-26
• In-Line ventilator adaptor2022-04-26
• TEG 5000 Functional Fibrinogen Reagent, Item No. 07-0342022-04-26
• CardioTek EP-TRACER Software V2.x.2022-04-25
• Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices manufactured on or after April 1, 20192022-04-25
• SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.2022-04-22
• Reliance Synergy Washer/Disinfector2022-04-22
• REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,2022-04-22
• Colonovideoscope Model CF-H180AL2022-04-22
• EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ1902022-04-22
• Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.2022-04-22
• 15 Liters Drain Bag2022-04-21
• 5 Prong Manifold Set (with Luer Connectors)2022-04-21
• Effluent Sample Bag2022-04-21
• APD Drain Manifold2022-04-21
• MEDLINE Polyurethane Foam Enzymatic Cleaning Sponge, REF DYK1000TSE2022-04-21
• MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS2022-04-21
• MEDLINE Polyurethane Bedside Cleaning Kit, REF DYK500FSAW2022-04-21
• MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK215FS2022-04-21
• MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK100FS2022-04-21
• PX200 Emergency Relief Bed; Model No. PXEXEB362280A6TTZZH4C192022-04-21
• ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier2022-04-21
• Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 150282022-04-21
• Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.2022-04-20
• Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation2022-04-20
• The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure, a deflectable catheter to introduce a transvenous device, a catheter dilator to facilitate deflectable catheter passage, and a guide catheter slitter to remove the deflectable cat2022-04-20
• Olympus CYSTONEPHROFIBERSCOPE Model: CYF-52022-04-20
• Olympus URETERO-RENO FIBERSCOPE Model: URF-P62022-04-20
• Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R2022-04-20
• LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 52022-04-19
• Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are v2022-04-19
• Back up batteries in Ventilators labeled as the following: a. CARESCAPE R860 Ventilators (K142679) b. ENGSTROM (K111116) c. ENGSTROM Carestation (K111116) d. ENGSTROM PRO (K111116)2022-04-18
• Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-2312022-04-18
• BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack2022-04-14
• HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU2022-04-14
• Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 109106202022-04-13
• GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 12022-04-13
• Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU2022-04-13
• Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD2022-04-13