FDA (Device enforcement)

11,102 recalls · page 56 of 112

• ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.28442023-12-15
• ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)7061102023-12-15
• ESG PK CUTTING FORCEPS, 5MM, 33CM2023-12-15
• FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)2023-12-14
• FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)2023-12-14
• Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection2023-12-13
• Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit2023-12-13
• DiaSorin LIAISON HSV-2 Type Specific IgG, REF 3106202023-12-13
• Spectral CT on Rails: Software Version 5.1.0.X, model 728334.2023-12-13
• Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.2023-12-13
• High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 01232023-12-12
• VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.2023-12-12
• Philips Azurion system, Interventional fluoroscopic x-ray system. System Product Name - Model Numbers Azurion 3M12 -722063, 722221; Azurion 3M15 - 722064, 722222; Azurion 5M12 - 722227; Azurion 5M20 - 722228; Azurion 7B12/12 - 722067, 722225; Azurion 7B20/15 - 722068, 722226; Azurion 7M12 - 722078, 2023-12-12
• Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF7542023-12-12
• Dual Articulating Headrest, Velcro P/N P141210813, REF BF7532023-12-12
• ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W2023-12-11
• Flow-i C20 Anesthesia System, model 66772002023-12-11
• Flow-i C30 Anesthesia System, model 66773002023-12-11
• Flow-i C40 Anesthesia System, model 66774002023-12-11
• Flow-c Anesthesia System, model 68877002023-12-11
• Flow-e Anesthesia System, model 68879002023-12-11
• Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S2023-12-11
• Globus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1842S2023-12-11
• Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref: 6143.1870S2023-12-11
• BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control voluntarily these physiological parameters.2023-12-11
• Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode2023-12-08
• Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord2023-12-08
• Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus2023-12-08
• Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus2023-12-08
• Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / QS6-BXXCS: b) QS6 AM12Q KIT BCRT IEC / QS-6CC-DGCXX: c) QS6 AM12Q KIT Z200 BCRT IEC / QS-6CC-DFCXX: d) QS6 AM12Q RS SYS AHA XML / QS-6JB-AXAXA: e) QS6 AM12Q SYS Z200 PCRT AHA XML / 2023-12-08
• XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d) XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) XS6 WAM TTL SYS Z200 AHA XML2023-12-08
• XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-030-50; b) X-SCRIBE CPI KIT WIRELESS USB 2500 MHz, 41000-030-51; c) X-SCRIBE CPI KIT DIRECT CONNECT USB, 41000-030-52; d) X-SCRIBE CPI KIT QUICK CONNECT USB, 410002023-12-08
• Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)2023-12-08
• Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)2023-12-08
• Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator2023-12-08
• ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.21002023-12-07
• Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 4598011798712023-12-07
• MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G444292023-12-07
• Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D12023-12-07
• Terragene Integron IT26-C Terragene Integron IT26-C with extender Benco Dental Chemical Integrator [5726-583] Tuttnauer (WTL198-0082) Terragene Integron (PCD26-C) Terragene Bionova PCD (PCD222-C)2023-12-07
• Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key2023-12-07
• Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key2023-12-07
• Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key2023-12-07
• Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key2023-12-07
• Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key2023-12-07
• Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key2023-12-07
• Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key2023-12-07
• Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key2023-12-07
• Impella Connect, software portal for online device management that allows clinicians and Impella support staff to remotely view Impella data.2023-12-06
• Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12MM, 1.00 MM GLOBAL; b) Product Code 50150: 12MM, 1.50 MM GLOBAL; c) Product Code 50175: 12MM, 1.75 MM GLOBAL; d) Product Code 50200: 12MM, 2.00 MM GLOBAL; e) Product Code 50225: 12MM,2023-12-06
• Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 9340722023-12-06
• Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL2023-12-06
• Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US2023-12-06
• Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.25 GLOBAL; c) Product Code FT12150, 1.50 GLOBAL; d) Product Code FT12175, 1.75 GLOBAL; e) Product Code FT12200, 2.00 GLOBAL; f) Product Code FT12225, 2.25 GLOBAL; g) Product Code FT1222023-12-06
• Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4 CMUS, TS d) PG0608: 6 X 8CMUS, TS e) PG0814: 8 X 14 CMUS, TS2023-12-06
• Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CMUS, d) PC0608NBIO: 6X8CMUS, e) PC0814NBIO: 8X14CMUS2023-12-06
• PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 CM US, TS; d) SPG0814: 8 X 14 CM US, TS; e) PC1016SNBIO: 10X16 CM US; f) PC0404SNBIO: 4X4 CM US; g) PC0608SNBIO: 6X8 CM US; h) PC0814SNBIO: 8X14 CM US2023-12-06
• Accure Laser System, Model: PFMS000042023-12-06
• Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US22023-12-05
• Ultrasound EA (Ergonomic Advantage) table versions; G2 (GENERAL 2) -An Ultrasound examination table2023-12-05
• Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table2023-12-05
• Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}2023-12-05
• Ultrasound EA (Ergonomic Advantage) table version; V2 (Vascular 2 Section) Echocardiography -An Ultrasound examination table2023-12-05
• SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS2023-12-04
• Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, 6 Fr/Ch (2.0 mm); Argyle" Graduated Suction Catheter Tray with Chimney Valve Sterile Saline 8 Fr/Ch (2.67 mm); Argyle" Suction Catheter Tray with Chimney2023-12-04
• Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, NEEDLE PORT, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, NEEDLE, 16 FR (5.3 MM), 5 CC, 2000 ML BAG; Dover" UNIVERSAL TRAY, 1000 ML BASIN, PVP SOLUTION, PREPPING COMPONENTS, 10 ML PRE-FILLED SYRINGE; Dover" U2023-12-04
• Dover URINE METER ADD-A-FOLEY TRAY, 200 ML, NEEDLE SAMPLING PORT, DRAIN TUBE, PREP TRAY; Dover UNIVERSAL TRAY, 1000 ML BASIN, PVP SWAB STICKS, PREPPING COMPONENTS, 30 CC PRE-FILLED SYRINGE; Dover URINE DRAINAGE ADD-A-FOLEY TRAY, NEEDLE SAMPLING, A/R, DRAIN TUBE, PREP TRAY, 30 ML SYRINGE; Dover HYDRO2023-12-04
• Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 18FR (6.0 MM), 5CC,2023-12-04
• Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" U2023-12-04
• Dover" 100% SILICONE FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover2023-12-04
• Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY, LL, 18 FR (6.0 MM), 5CC, 2000ML DRAIN BAG, CSD2023-12-04
• Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .2023-12-01
• Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.2023-12-01
• SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, TFL-FBX150BS, TFL-FBX200BS2023-12-01
• SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-00262023-12-01
• SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-00282023-12-01
• SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-00302023-12-01
• SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-00322023-12-01
• SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-05152023-12-01
• SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-05242023-12-01
• SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-03212023-12-01
• SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-05102023-12-01
• SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-75122023-12-01
• SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-75142023-12-01
• SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-75162023-12-01
• SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-75182023-12-01
• SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-75212023-12-01
• SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-75242023-12-01
• Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-03242023-12-01
• Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-09082023-12-01
• Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-09102023-12-01
• SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-01102023-12-01
• SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-05102023-12-01
• SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-07102023-12-01
• SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-09102023-12-01
• SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-21102023-12-01
• SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-27102023-12-01
• SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-29102023-12-01
• SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-31102023-12-01
• SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-33082023-12-01