FDA (Device enforcement)

11,102 recalls · page 34 of 112

• AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M005536702024-12-20
• AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M005536902024-12-20
• HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M005535202024-12-20
• HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M005535302024-12-20
• HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M005535402024-12-20
• HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M005535502024-12-20
• HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M005535602024-12-20
• HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M005535702024-12-20
• PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.2024-12-20
• PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.2024-12-20
• ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US2024-12-20
• 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 4701792024-12-19
• 8MM, POTTS SCISSORS, IS4000 REF 4700012024-12-19
• 8MM, LARGE NEEDLE DRIVER, IS4000 REF 4700062024-12-19
• 8MM, ROUND TIP SCISSORS, IS4000 ¿ REF 4700072024-12-19
• 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 4700332024-12-19
• 8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 4700362024-12-19
• 8MM,CADIERE FORCEPS,IS4000 ¿ REF 4700492024-12-19
• 8MM,PROGRASP FORCEPS,IS4000 ¿ REF 4700932024-12-19
• 8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 4701712024-12-19
• 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 4701722024-12-19
• 8MM,RESANO FORCEPS,IS4000 ¿ REF 4701812024-12-19
• 8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 4701942024-12-19
• 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 4702052024-12-19
• 8MM,TENACULUM FORCEPS,IS4000¿ REF 4702072024-12-19
• 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000¿ REF 4702302024-12-19
• 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 4702462024-12-19
• 8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 4702492024-12-19
• 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000¿ REF 4702962024-12-19
• 8MM,MEGA SUTURECUT ND,IS4000¿ REF 4703092024-12-19
• 8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 4703182024-12-19
• 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000¿ REF 4703272024-12-19
• 8MM,CURVED BIPOLAR DISSECTOR,IS4000¿ REF 4703442024-12-19
• 8MM,TIP-UP FENESTRATED GRASPER,IS4000¿ REF 4703472024-12-19
• 8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 4704012024-12-19
• 8MM,FORCE BIPOLAR,IS4000 REF 4704052024-12-19
• 8MM,LONG TIP FORCEPS,IS4000 REF 4710482024-12-19
• 8MM,CADIERE FORCEPS,IS4000 REF 4710492024-12-19
• 8MM,PROGRASP FORCEPS,IS4000 REF 4710932024-12-19
• 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 4711712024-12-19
• 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 4711722024-12-19
• 8MM,COBRA GRASPER,IS4000 REF 4711902024-12-19
• 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 4712052024-12-19
• 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 4712962024-12-19
• 8MM,MEGA SUTURECUT ND,IS4000 REF 4713092024-12-19
• 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 4713442024-12-19
• 8MM,LONG BIPOLAR GRASPER,IS4000 REF 4714002024-12-19
• 8MM,FORCE BIPOLAR,IS4000 REF 4714052024-12-19
• 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.2024-12-19
• 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.2024-12-19
• BD PCR Cartridges used with MAX System. Model Number: 4375192024-12-19
• Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415 (Certified/Refurbished), 6904001 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, no2024-12-19
• Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a compo2024-12-19
• Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: 2024-12-19
• Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each), Model: C-CA-23, Item: 33516;2024-12-19
• Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;2024-12-19
• Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.2024-12-18
• GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission2024-12-18
• GE Healthcare Brivo NM 615, Model/Catalog Numbers: 1) 5376204-15, 2) H2401MA, 3) H3100TA; System, Tomography, Computed, Emission2024-12-18
• GE Healthcare Discovery NM 630, Model/Catalog Numbers: 1) 5376204-30-2, 2) H2401CF, 3) H2401CH, 4) H2401JE, 5) H3100JY; System, Tomography, Computed, Emission2024-12-18
• GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emission2024-12-18
• GE Healthcare Discovery NM/CT 670 DR, Model/Catalog Numbers: 1) 5376204-70-56-2; 2) H2401AW; 3) H3100AN; 4) H3100BT; 5) H3100PX; System, Tomography, Computed, Emission2024-12-18
• GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission2024-12-18
• GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission2024-12-18
• GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; System, Tomography, Computed, Emission2024-12-18
• GE Healthcare Infinia II, Model/Catalog Numbers: 1) H2799ZP; 2) H3000WT; System, Tomography, Computed, Emission2024-12-18
• GE Healthcare Infinia I Hawkeye 1, Model/Catalog Numbers: 1) H3000WN; 2) H3000YM; 3) H3000YS; System, Tomography, Computed, Emission2024-12-18
• GE Healthcare Infinia II Hawkeye 4, Model/Catalog Numbers: 1) H2799PP; 2) H2799PR; 3) H2799YC; 4) H2799YD; 5) H3000WC; 6) H3000WD; 7) H3000WT; 8) H3000WW; 9) H3000WY; 10) H3000WZ; System, Tomography, Computed, Emission2024-12-18
• GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission2024-12-18
• HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic2024-12-18
• Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RED, Item Number 949000221; 2024-12-16
• Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341; 3) MTO,ANGIO,SINGLE,SPIKE,KIT, Item Number: 65232486; 4) MTO,ANGIO,SINGLE,SPIKE,KIT,GOOD,SAM, Item Number: 65071193; 5) MTO,2024-12-16
• CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.2024-12-16
• CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.2024-12-16
• CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.2024-12-16
• Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia2024-12-16
• Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 cm (50"), REF US502, to prevent or treat hypothermia2024-12-16
• Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm (35"), REF US530, to prevent or treat hypothermia2024-12-16
• Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, Part #325-07102515, nonst2024-12-15
• Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.2024-12-13
• ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)2024-12-12
• PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).2024-12-12
• ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)2024-12-12
• ALTRUA 2 DR Pacemaker, SL (Model Number S702) and EL (Model Number S722)2024-12-12
• VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)2024-12-12
• VISIONIST CRT-P, EL (Model Number U225 and U226) and EL MRI (Model Number U228)2024-12-12
• Impella RP with SmartAssist; Product Number: 0046-0035;2024-12-12
• Impella RP Flex with SmartAssist; Product Number: 1000323;2024-12-12
• SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).2024-12-12
• SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).2024-12-12
• Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 10035802024-12-11
• Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 10508422024-12-10
• Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150, Size: 5MM X 60MM X 150CM; 6) AB14W0500802024-12-10
• VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.2024-12-09
• Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.2024-12-09
• JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L2024-12-09
• Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-00042024-12-06
• Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB2024-12-06
• LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for revision hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstructio2024-12-05
• Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxin is a widely prescribed card2024-12-05