FDA (Device enforcement)

11,102 recalls · page 55 of 112

• BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿2024-01-08
• Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.2024-01-08
• OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite2024-01-05
• Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe2024-01-04
• Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.2024-01-03
• 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch Communication System, HMT1150 The HeartMate Touch Application is loaded onto a tablet and will provide a user interface with state-of-the-art hardware/software platfo2024-01-03
• Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.2024-01-03
• Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.2024-01-03
• Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.2024-01-03
• Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.2024-01-03
• Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.2024-01-03
• SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.2024-01-03
• SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.2024-01-03
• Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/t2024-01-03
• The Prestige Coil System is a product family of embolic coils with associated delivery system components. These devices are angiographically delivered through the vasculature to embolize peripheral vascular abnormalities. The devices are to be placed to create blood stasis, reducing flow into the an2024-01-03
• The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. This test allows for the detection of SARS-CoV and SARS-CoV-2, but does not differentiate between the 2024-01-03
• Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument2024-01-03
• Synapse Cardiology PACS V7.3.0, V7.2, V7.1, V7.0. A web-based application as the primary user interface for the processing of medical images.2024-01-03
• Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.2024-01-03
• USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417 - 17x200mm,2024-01-03
• USTAR II Knee System Cemented curved stem, RHS, Non Coated for the following reference numbers: REF: PE25153109 - 9x125mm, PE25153209 - 9x150mm, PE25153113 - 13x125mm, PE25153111- 11x125mm, PE25153115 - 15x125mm, PE25153211 - 11x150mm, PE25153213 - 13x150mm, PE25153217 - 17x150mm, PE25153117 - 17x122024-01-03
• USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11X150, PE25151213 - 13X1502024-01-03
• 3:1 Dermacarrier, Model Number 00219501300, skin graft carrier2024-01-02
• Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD20 722002024-01-02
• Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: FlexViewing PC Azurion Model Name - Model Number: Azurion 7 B12 722067; Azurion 7 B20 722068; Azurion 7 M12 722078 722223; Azurion 7 M20 722079;2024-01-02
• Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of affected systems. Affected PCs: Imaging Processing PC, Host PC, FlexVision PC Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10 OR Table 7220222024-01-02
• Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azur2024-01-02
• Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xpe2024-01-02
• Achieva 1.5T, Model No. 781178, 781196, 7812962023-12-29
• Achieva 1.5T Conversion, Model No. 7812832023-12-29
• Ingenia Ambition X, Model No. 7821092023-12-29
• SmartPath to dStream for 1.5T, Model No. 781260, 7821122023-12-29
• MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";2023-12-29
• MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"2023-12-29
• Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE2023-12-28
• Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE2023-12-28
• Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE2023-12-28
• Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE2023-12-28
• Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 11801007772023-12-28
• Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 11803007772023-12-28
• Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 11806007772023-12-28
• Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777T2023-12-28
• Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 11820007772023-12-28
• Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 11835007772023-12-28
• Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777T2023-12-28
• Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE2023-12-28
• Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SE2023-12-28
• Bubble Sensor (REF: 70105.5720)2023-12-28
• Samsung Digital Diagnostic Mobile X-ray System, Model GM85.2023-12-28
• AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.2023-12-28
• Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Co2023-12-27
• Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with Sma2023-12-27
• Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA100022023-12-26
• HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty2023-12-22
• HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty2023-12-22
• Baxter Exactamix Pro 1200, REF EXM12DY2023-12-22
• Baxter Exactamix Pro 2400, REF EXM24DY2023-12-22
• CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-5102023-12-21
• Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Suction Canister Liner Kit with 5 mm 1.8 m Tube, REF 65651-5162023-12-21
• Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-5172023-12-21
• Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT2023-12-21
• Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S2023-12-21
• TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S6002023-12-21
• MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694A2023-12-21
• MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738A2023-12-21
• MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A2023-12-21
• MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1626B2023-12-21
• MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH17232023-12-21
• MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622C2023-12-21
• MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194A2023-12-21
• HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)2023-12-21
• Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN00421202023-12-20
• Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN00421402023-12-20
• Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN00421602023-12-20
• Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN00460002023-12-20
• Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN00461002023-12-20
• Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN00461202023-12-20
• Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN00461402023-12-20
• Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN00461602023-12-20
• Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN00461802023-12-20
• Bard¿ Lopez Valve¿ with ENFit, REF EN00560002023-12-20
• Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN00561802023-12-20
• Bard¿ Suction Connector with ENFit, REF EN00660002023-12-20
• global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.2023-12-20
• These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungicidal activites. MEDLINE MICRO-KILL Bleach GERMICIDAL BLEACH WIPES: a) MSC351400AN/Z (7 X 8 , 150 ct canister), b) MSC351410AN/Z (6 x 5 , 150ct caniste2023-12-20
• Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF2023-12-20
• Model A710 Intellis Clinician Programmer Application, version 2.0.972023-12-19
• Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C769472023-12-19
• iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C106842023-12-19
• iQ Waste Well Adapter, Part Number: 700-33932023-12-19
• Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T2023-12-19
• EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.2023-12-19
• Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate Long, Left; 70-00472023-12-19
• Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-5002023-12-19
• Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,2023-12-19
• Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010E2023-12-19
• TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.2023-12-18
• Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.252023-12-18
• PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.2023-12-18
• Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry2023-12-15