FDA (Device enforcement)

11,102 recalls · page 70 of 112

• Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 59554502023-04-25
• Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU only)2023-04-25
• Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU Only)2023-04-25
• Incisive CT-Computed Tomography X-Ray System Model: 7281432023-04-25
• Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 7281462023-04-25
• Incisive CT Power (China)-Computed Tomography X-Ray System Model: 7281482023-04-25
• Incisive CT Plus-Computed Tomography X-Ray System Model: 7281492023-04-25
• FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software2023-04-25
• Xpert Xpress Strep A, XPRSTREPA-10, P/N: 302-2294 IVD, Rx Only2023-04-24
• Xpert Xpress Strep A, REF:Xprstrepa-CE-10, CE IVD,2023-04-24
• Alinity i Anti-TPO Reagent Kit, List Number 09P35212023-04-24
• Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only2023-04-22
• Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only2023-04-22
• Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only2023-04-22
• Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only2023-04-22
• Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only2023-04-22
• Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only2023-04-22
• Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only2023-04-22
• Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only2023-04-22
• Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only2023-04-22
• Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only2023-04-22
• Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only2023-04-22
• Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only2023-04-22
• Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only2023-04-22
• Procedure packs: (1) Medline Sterile Arthroscopy Pack, REF: DYNJ64242B; (2) Medline Sterile Shoulder Pack, REF: DYNJ64250A; and (3) Medline Sterile Upper Extremity Pack, REF: DYNJ64253B.2023-04-21
• Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 40532023-04-21
• Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 17942023-04-21
• Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 18952023-04-21
• Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 25032023-04-21
• Magic3 Go Intermittent Urinary Catheters, Female Catalog Numbers: a) REF 51808, b) REF 51810, c) REF 51812, d) REF 51814, e) REF 51816, f) REF 518182023-04-20
• Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G2023-04-20
• Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.12023-04-19
• Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N57861002023-04-18
• VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 68429052023-04-17
• Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 82023-04-17
• Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05, OB-OR C-SECTION PACK, Carilion Roanoke Memorial Hospital.2023-04-17
• RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A00265772023-04-14
• RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sedimentation Rate (ESR) instruments and procedures. Product Code: A00265782023-04-14
• TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E2023-04-13
• TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E2023-04-13
• DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 2127242023-04-13
• DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 2127252023-04-13
• DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 2127262023-04-13
• DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 2127222023-04-13
• DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 2127232023-04-13
• Incisive CT- whole-body computed tomography (CT) X-Ray System Model Number: 7281442023-04-12
• Incisive CT- Whole-body computed tomography (CT) X-Ray System Model Number: 728143 (OUS)2023-04-12
• Incisive CT Power- Whole-body computed tomography (CT) X-Ray System Model Number: 728148 (OUS)2023-04-12
• Incisive CT Plus -Whole-body computed tomography (CT) X-Ray System Model Number: 728149 (OUS)2023-04-12
• Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM2023-04-11
• Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-66072023-04-11
• StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems2023-04-11
• StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems2023-04-11
• Reliance Vision Multi-Chamber Washer/Disinfector, Reference Number FH830622023-04-10
• Over-Head Ceiling Tube Support, CH-200, CH-200M, Used with RadSpeed and RadSpeed PRO, Sonial Vision safire, Versa and G4 units, FluoroSpeed 300 and X1 units2023-04-10
• Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FLEX7.5 (G57691), C-PTIS-100-HC-G-NA-FLEX8.5 (G57692)2023-04-07
• Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Numbers C-PTISYJ-100-HC-G-EU-FLEX8.5 (G57725), C-PTISYJ-100-HC-G-NA-FLEX7.5 (G57720), C-PTISYJ-100-HC-G-NA-FLEX8.5 (G57721), C-PTISY-100-HC-G-NA-FLEX8.5 (G57717), C-PTISY-100-HC-G-NA-FLEX7.5 (G57716)2023-04-07
• Fisher Wallace Stimulator Models FW-100 and FW-2002023-04-06
• 3M Attest Steam Chemical Integrators, REF 1243A2023-04-06
• 3M Attest Steam Chemical Integrators, REF 1243B2023-04-06
• Elekta Unity Image-Guided Radiation Therapy System containing an MR gradient coil.2023-04-06
• Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF: 39501A2; Wire Tray f. Clean2023-04-06
• BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 3522023-04-05
• Draeger Infinity CentralStation (ICS), centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment, Software versions VG2.1.3 and lower2023-04-05
• Draeger Infinity M300 and M300+, for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network,2023-04-05
• BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-012023-04-05
• WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)2023-04-05
• iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-33252023-04-05
• Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL2023-04-05
• Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL2023-04-05
• Beckman Coulter Bicarbonate, REF: OS6637, 4x173 mL2023-04-05
• ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA¿ Chemistry systems Siemens Material Number (SMN): 103092172023-04-05
• Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica¿ CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica¿ CH Analyzer Siemens Material Number (SMN): 110994402023-04-05
• NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software2023-04-05
• MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.2023-04-05
• KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A2023-04-05
• MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-322023-04-04
• Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 21649301S, g) 21649401S, h) 21649402S, i) P006800A01, j) P006800A02, k) P3255A01, l) P3255A02, m) P3255A03, n) P3255ARENT01, o) P7923A01, p) P7923A02, q) P7923A03, r) P7923A04, s) P72023-03-31
• PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H2023-03-31
• ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A2023-03-31
• To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A2023-03-31
• Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 2088026-613, m) 2088026-713, n) 20882023-03-28
• DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs2023-03-28
• JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM2023-03-27
• Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CUFFED TRACH CAN; 10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF; 10UN10A, 10.0MM UNCUFF TRACH TUBE X1; 10UN10H, 10.0MM SHILEY C2023-03-24
• FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.0512023-03-24
• FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.0512023-03-24
• FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 8735.6852023-03-24
• FLEX. GRASP. FORCEPS 6.6FR WL 550MM, Product Number 8736.6852023-03-24
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC2023-03-24
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC2023-03-24
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC2023-03-24
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC2023-03-24
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC2023-03-24
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC2023-03-24
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC2023-03-24
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM2023-03-24
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE2023-03-24
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE2023-03-24
• ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE2023-03-24