FDA (Device enforcement)

11,102 recalls · page 79 of 112

• Disposable Subdermal Needle Electrode, Pt/lr, 12 x 0.40mm, product number TE/S46/638, 25 needles per package, sterile.2022-08-09
• The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Mark2022-08-09
• LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.2022-08-05
• MEGA 8Fr 50cc Intra-Aortic Balloon Catheter2022-08-05
• Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter2022-08-05
• Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter2022-08-05
• CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A, CORA1810/B, CORA1810S/B, CORA1815/A, CORA1815/B, CORA1815S/A, CORA1815S/B, CORA1820/A, CORA1820/B, CORA1820S/A, CORA1825/A, CORA1825/B, CORA1825S/A, CORA2010/A, CORA2010/B, CORA2010S/A, CORA2015/A, CORA2015/B, CORA2022-08-03
• Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schumacher TAPE, 2.5cm x 7.5cm x 1mm2022-08-03
• MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. ET LENGTH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12; b. ET LENGTH DOUBLE SWIVEL, 14 Fr, Item Number/REF: DYNCPDS14; c. ET LENGTH2022-08-03
• MEDLINE CLEARPRO TRACH DOUBLE SWIVEL CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH DOUBLE SWIVEL, 12 Fr, Item Number/REF: DYNCPDS12T b. TRACH DOUBLE SWIVEL, 14 Fr, Item Number/REF: DYNCPDS14T2022-08-03
• MEDLINE CLEARPRO TRACH T-PIECE CLOSED SUCTION CATHETER, flat peel pouch EA, 10 EA per Inner Carton (IC), 20 EA/2 Inner cartons per Case (CS). Labeled as follows: a. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14; b. TRACH T-PIECE, 14 Fr, Item Number/REF: DYNCPTP14T2022-08-03
• BD MaxGuard Extension Set with 4-way stopcock, REF: M40582022-08-01
• BD MaxGuard Extension Set, REF: ME10692022-08-01
• BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS1062022-08-01
• BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS1412022-08-01
• BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX44362022-08-01
• BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX90592022-08-01
• BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX91662022-08-01
• BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX91712022-08-01
• BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX94332022-08-01
• The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc, and Anti Treponema pallidum IgG. The product is delivered as a liquid in a kit of 3 identical ready-to-use vials of 5 mL each.2022-08-01
• 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; (3) 191124 2008T HD SYS. CDX BLUESTAR; (4) 191126 2008T HD SYS. 2022-07-27
• ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM2022-07-27
• Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD2022-07-26
• Nobel Biocare N1 TiUltra TCC NP 3.5x13mm2022-07-25
• Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100, c) 25 pack, REF H9386900252022-07-22
• Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H9386731002022-07-22
• Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, REF H938691002022-07-22
• BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.2022-07-22
• BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.2022-07-22
• BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.2022-07-22
• BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.2022-07-22
• Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)2022-07-21
• Medline CHEST TUBE REORDER NO: DYNJ36762A2022-07-21
• TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001. For circulatory or cardiopulmonary bypass.2022-07-21
• Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.2022-07-21
• Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 68820002022-07-20
• NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.2022-07-20
• VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 68444582022-07-19
• VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 68444612022-07-19
• Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.2022-07-19
• Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.2022-07-19
• Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures.2022-07-19
• Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.2022-07-19
• Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.2022-07-19
• Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional procedures.2022-07-19
• Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.2022-07-19
• Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.2022-07-19
• Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.2022-07-19
• Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.2022-07-19
• Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.2022-07-19
• Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.2022-07-19
• Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.2022-07-19
• DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psychiatric, University, REF 2022-07-15
• (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.2022-07-15
• Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 7951222022-07-14
• cobas e801 Immunoassay Analyzer2022-07-14
• The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.2022-07-14
• EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System2022-07-14
• VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.92022-07-13
• AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo LOW 6634633; AXIOM Sensis, Combo 32 6634641; AXIOM Sensis, EP 129 6634658; Sensis 10764561; Sensis Vibe Combo 11007642; Sensis recording system is intended to be used as a diagn2022-07-12
• SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C2022-07-12
• Surpria: Software Version V3.11, V3.222022-07-12
• Surpria 64: Software Version V3.11, V3.222022-07-12
• SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-011982022-07-11
• NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.2022-07-11
• INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.2022-07-10
• Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.2022-07-08
• Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.2022-07-08
• Pentacam HR REF 70900. Used to image the anterior segment of the eye.2022-07-08
• ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S2022-07-07
• The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.2022-07-07
• The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.2022-07-07
• The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.2022-07-07
• ZAP-X Radiosurgery System2022-07-05
• Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD2022-07-04
• Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE052022-07-04
• Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 4200032022-07-01
• Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 474012022-07-01
• SX-One MicroKnife2022-06-29
• ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 2544005252022-06-29
• Wolf-Pak Premium Dressing Kit with GuardVA Cs/30 Ref: DC5030LF2022-06-29
• Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF2022-06-29
• Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090LF2022-06-29
• CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.2022-06-29
• Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN2022-06-29
• Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.2022-06-28
• HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE2022-06-28
• (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.2022-06-27
• X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)2022-06-27
• HAMILTON-C6 Intensive Care Ventilator, REF: 1600212022-06-27
• Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag Spike w ChemoLock Port/CL2150; 2022-06-27
• Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.2022-06-24
• Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03.2022-06-24
• Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01.2022-06-24
• Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02.2022-06-24
• Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01.2022-06-24
• Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03.2022-06-24
• Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04.2022-06-24
• SIGNA Premier magnetic resonance scanner, model 5748519.2022-06-24