FDA (Device enforcement)

11,102 recalls · page 74 of 112

• Ultracell Wick with 80cc Collection Bag, 20/box2022-12-20
• CustomEyes kits2022-12-20
• Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-32, 0998-UC-0800-2022-12-19
• Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.2022-12-19
• BIOSTOP G BIORESORBABLE CEMENT RESTRICTOR Catalog Numbers: 546308000 (Size 8); 546310000 (Size 10); 546312000 (Size 12); 546314000 (Size 14); 546316000 (Size 16); 546318000 (Size 18); 546320000 (Size 20)2022-12-19
• GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 830 NM Cyber Defense Configuration2022-12-19
• GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, 2022-12-19
• Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)2022-12-19
• ARTIS pheno, ARTIS icono biplane, and ARTIS icono floor2022-12-16
• System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 1084832022-12-16
• Lucid TCD 2.0 System, Model: NA-LUCM1. Transcranial Ultrasound System2022-12-16
• NovaGuide Intelligent Ultrasound System, Model: NA-RBTSYS1. Comprised of NovaBot Automated Headset (AKA: NeuralBot, Model: NA-RBT1) and Lucid TCD 2.0 Transcranial Doppler Ultrasound (Model: NA-LUCM1)2022-12-16
• Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW2022-12-16
• Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 1543412022-12-15
• AxiEM" Non-Invasive Patient Tracker2022-12-15
• HIGH V+ Spinal Cement System REF T040321K2022-12-15
• Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-21862022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-21872022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-21882022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-21892022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-21902022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-21912022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-22102022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-22112022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-22122022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-22132022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-22142022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-22152022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-22162022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-22172022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-22212022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-22232022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-22252022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-22262022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-22272022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-22282022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-22292022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-22302022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-22312022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-22322022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-22332022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-22342022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-22902022-12-14
• Cardinal Health Jackson-Pratt Channel Drain, 32 Fr, REF JP-22922022-12-14
• GORE CARDIOFORM Septal Occluder, REF: GSX0030A2022-12-14
• SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)2022-12-13
• VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes2022-12-12
• VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes2022-12-12
• VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes2022-12-12
• VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes2022-12-12
• DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.102022-12-12
• BD Pyxis MedBank System - Product Label/labeling pending2022-12-12
• cobas infinity central lab, Material Number 071540030012022-12-12
• Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.2022-12-12
• Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.2022-12-12
• Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.2022-12-12
• Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.2022-12-12
• Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.2022-12-12
• Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.2022-12-12
• epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 1073642022-12-12
• epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 114135832022-12-12
• CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-242022-12-09
• CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302-24, 4) REF 21-7321-24, 5) REF 21-7322-24, 6) REF 21-7323-24, 7) REF 21-7324-24, 8) REF 21-7333-24, 9) REF 21-7336-24, 10) REF 21-7339-24, 11) REF 21-7343-24, 12) REF 21-7349-24, 13) REF 21-7359-24, 14) REF 21-2022-12-09
• CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device2022-12-09
• CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-7624-24, d) REF 21-7649-24, e) REF 21-7600-24JP, f) REF 21-7609-24JP, g) REF 21-7624-24JP, h) REF 21-7649-24JP Computerized Ambulatory Delivery Device2022-12-09
• CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-7302-24, 4) REF 21-7308-24, 5) REF 21-7309-24, 6) REF 21-7310-24, 7) REF 21-7322-24, 8) REF 21-7323-24, 9) REF 21-7324-24, 10) REF 21-7333-24, 11) REF 21-7343-24, 12) REF 21-7346-24, 13) REF 21-7349-24, 14) REF 212022-12-09
• Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus Max2022-12-09
• RadiaLux Lighted Retractor (Pink), REF: 50-101-12022-12-08
• Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation2022-12-08
• Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal in2022-12-08
• Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; d. RUSCHELIT Safety Cl2022-12-08
• MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888135132; 13.5cm, Pre-Curved, Kit - Model No. 8888135133; 13.5cm, Straight Extensions, IC Tray, Model No.2022-12-07
• Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096, R1054655TP, R105462022-12-07
• Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B2022-12-07
• Philips Garbin Ventilator, Model Number 1058180B2022-12-07
• 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium2022-12-07
• 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel2022-12-07
• Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium2022-12-07
• 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium2022-12-07
• 7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium2022-12-07
• Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium2022-12-07
• 7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium2022-12-07
• 6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium2022-12-07
• Pediatric Craniotome Ref:CRANI-P-G12022-12-07
• IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # L2K2022-12-07
• IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # Catalog # L2KTY2 Siemens Material Num2022-12-07
• MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.2022-12-07
• Veritas Advanced Infusion Packs, REF: VRT-AI2022-12-07
• FUSION Dual Pump Packs, REF: OPO732022-12-07
• Single-Use Packs, REF: OPO802022-12-07
• Identity Shoulder System Resection Planer 35mm Resection Planer2022-12-07
• Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION MEDICAL PRODUCTS DIALYSIS ON/OFF BUNDLE, Reorder Number DT22705A c) CENTURION MEDICAL PRODUCTS ULTRASOUND PIV BUNDLE, Reorder Number IV8635D d) CENTURION MEDICAL PRODUCTS CUTDOWN TRAY, Reorder Num2022-12-07
• Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number CVI2105; b) CENTURION MEDICAL PRODUCTS VASECTOMY KIT, Reorder Number MNS11975; c) CENTURION MEDICAL PRODUCTS LACERATION TRAY, Reorder Number SUT11670; d) CENTURION MEDICAL PRODUCTS LACERATIO2022-12-07
• Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,2022-12-07
• Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850; b) MEDLINE SHOULDER SUSPENSION II-LF, Reorder Number DYNJSHOULDER2; c) MEDLINE TRAY BONE MARRO ASC LTX SAFE, Reorder Number P429589A; d) MEDLINE LUMBAR TRAY, Reorder Number SPEC0177; e) CENTURION MEDICAL PRODUCTS L2022-12-07
• Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.2022-12-06
• Oncentra Brachy radiation therapy planning system software.2022-12-05
• SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.2022-12-05
• Agfa HealthCare Enterprise Imaging XERO Viewer2022-12-05
• Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A2022-12-03