FDA (Device enforcement)

11,102 recalls · page 84 of 112

• SS 3.2MM Pellet Insertion Tray Catalog Number: B8110R12022-02-22
• 4.5 MM Pellet Insertion Tray Catalog Number: B8121R12022-02-22
• Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R12022-02-22
• Male SS 4.5MM Pellet Insertion Tray Catalog Number: B9176R12022-02-22
• 3.2MM Pellet Insertion Tray Catalog Number: B97432022-02-22
• Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.2022-02-21
• Signa 1.5T TwinSpeed Magnetic Resonance Imaging System2022-02-18
• 1.5T SIGNA Excite HD, 3.0T SIGNA Excite HD. Magnetic Resonance Imaging System2022-02-18
• SIGNA Excite 3T. Magnetic Resonance Imaging System2022-02-18
• 1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System2022-02-18
• Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product C2022-02-18
• ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.0252022-02-18
• NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection Note: Res2022-02-18
• Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.2022-02-17
• ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 2352022-02-15
• Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 1308402022-02-15
• BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels o2022-02-14
• BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriat2022-02-14
• BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.2022-02-14
• BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill Bit, Item # 8290321702022-02-14
• Compella Bariatric Bed System2022-02-14
• Compella Therapy Air Supply Unit2022-02-14
• Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP G52916; IGTCFS-65-1-UNI-TULIP G529182022-02-14
• Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-FEM-CELECT-PT G34502; IGTCFS-65-1-JUG-CELECT-PT G34309; IGTCFS-65-1-UNI-CELECT-PT G34505;2022-02-14
• Alinity m Integrated Reaction Units (IRU)2022-02-11
• RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6/RayPlan 2 (6.0.0.24), RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2), RayStation 6/RayPlan 2 Service Pack2022-02-11
• CombiDiagnost R90 1.0 (709030)2022-02-11
• CombiDiagnost R90 1.1 (709031)2022-02-11
• Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001. Labeled REF UA-5001.2022-02-09
• Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 110975362022-02-09
• BioPlex 2200 REF 12000650 SYPH T PACK Syphilis Total & RPR Reagent Pack2022-02-08
• BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL2022-02-08
• PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U2022-02-07
• The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.2022-02-07
• Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodi2022-02-03
• Cardiovascular Procedure Kit catalog # 76645 & 738062022-02-03
• NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 50992502022-02-02
• Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Versio2022-02-02
• Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC SM, Part ID 168132022-02-01
• Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC MD, Part ID 168142022-02-01
• Titanium MPJ (Toe Implant) TOE JOINT TITANIUM NPC ML, Part ID 168152022-02-01
• Titanium MPJ (Toe Implant)TOE JOINT TITANIUM NPC LG, Part ID 168162022-02-01
• Titanium MPJ (Toe Implant)TOE JOINT TITANIUM PC SM, Part ID 170352022-02-01
• Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MD, Part ID 170362022-02-01
• Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC MS, Part ID 171972022-02-01
• Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)2022-02-01
• (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOB2022-02-01
• Dispensing Pins for Air Inlet Filter, Product Catalog No. 412005, DP2500 Dispensing Pin W/Valve. A valve for aspiration or injection of medication or enteral feeding solution from inverted multi-dose vials.2022-01-31
• SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-092022-01-28
• GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.2022-01-28
• LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenish2022-01-27
• LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishment2022-01-27
• LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. La2022-01-27
• BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C2022-01-27
• BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C2022-01-27
• Philips Respironics V60 Ventilator Part Number 10536172022-01-24
• Philips Respironics V60 Plus Ventilator Part Number 11387472022-01-24
• IntraSight Mobile IVUS Systems, Model: 797415, Part numbers: 300002018101, 3000020181022022-01-24
• 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C devices)2022-01-21
• Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray, 22 g x 1.5" Spinal Needle with Manometer2022-01-20
• LUMBAR PUNCTURE TRAY PEDIATRIC 21G 2.52022-01-20
• LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP2022-01-20
• ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G2022-01-20
• SAFE-T PLUS LUMBAR PUNCTURE TRAY ADULT2022-01-20
• LUMBAR PUNCTURE TRAY ADULT 18G X 3.52022-01-20
• LUMBAR PUNCTURE TRAY ADULT 22G X3.5 STRL2022-01-20
• SAFE-T PLUS LUMBARPUNCTURE TRAY ADULT2022-01-20
• ATRAUMATIC ADULT LUMBAR PUNCTURE TRAY2022-01-20
• LUMBAR PUNCTURE DRUG FREE TRAY 22G2022-01-20
• SAFE-T PLUS ATRAUMATIC ADULT LP TRAY2022-01-20
• Outset Tablo Console Model Number: PN-0003000 Model Number: PN-00060002022-01-20
• SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x2022-01-19
• Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML or MDS Catalog Number: USA-LPH0242022-01-18
• LINQ II Insertable Cardiac Monitor2022-01-18
• 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.2022-01-14
• HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR GRAFT- D: 7 mm; L: 60 cm Indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. Product Code/REF Number: M0020209520702022-01-14
• Biolox delta Ceramic V40 Femoral Head 32/ -4.0mm Catalog Number: 6570-0-0322022-01-14
• Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-2322022-01-14
• Everest MI XT Inner Dilator, Catalog Number 5101-901672022-01-13
• Everest MI XT Outer Dilator, Catalog Number 5101-901682022-01-13
• Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT2022-01-13
• Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT2022-01-13
• Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native art2022-01-11
• Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of2022-01-11
• Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) 2022-01-11
• Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of na2022-01-11
• Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistu2022-01-11
• 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rot2022-01-11
• Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialy2022-01-11
• Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-3013012022-01-07
• Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 1136112022-01-07
• Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 1136142022-01-07
• Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 1136182022-01-07
• Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 1136312022-01-07
• Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 1136322022-01-07
• Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 1136332022-01-07
• Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 1136352022-01-07
• NavitrackER Kit A: Knee, Model Number 20-8000-000-07,2022-01-07
• BD Vacutainer Luer Lok Access Device - intended as a sterile, single use device designed to provide a connection to a catheter port equipped with a threaded female luer during blood or urine sample collection using evacuated BD Vacutainer Blood or Urine Collection Tubes Catalog Number: 364902, 364902022-01-06
• Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system2022-01-06