FDA Device · 2017
FDA Device recalls in 2017
RecallRadar indexes 2,615 FDA Device recall notices published in 2017. By classification: 51 Class I, 2,510 Class II, 54 Class III.
- Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Code KC715
FDA Device · Class II · 2017-12-06 · Siemens Healthcare Diagnostics - ROSA Surgical Device 2.5.8
FDA Device · Class II · 2017-12-06 · Zimmer Biomet - Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientatio…
FDA Device · Class II · 2017-12-06 · Zimmer Biomet - SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (L…
FDA Device · Class II · 2017-12-06 · Csl Behring - Volcano Imaging System s5i REF 807400001
FDA Device · Class II · 2017-12-06 · Volcano - ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet The Pressure Injectable PICC is indicated for short or long term peripheral access to the central…
FDA Device · Class II · 2017-12-06 · Arrow International - BD Insulin Syringes with the BD Ultra-Fine(TM) needle ¿ mL 12.7mm 30G, Catalog/REF 328466 BD Insulin Syringes are intended for the subcutan…
FDA Device · Class II · 2017-12-06 · Becton Dickinson And - Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product Code KC717
FDA Device · Class II · 2017-12-06 · Siemens Healthcare Diagnostics - Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
FDA Device · Class II · 2017-11-29 · Medtronic - Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure
FDA Device · Class II · 2017-11-29 · Resource Optimization And Innovation - NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 20 k…
FDA Device · Class II · 2017-11-29 · Halyard Health - Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - ROSA Surgical Device 2.5.8
FDA Device · Class II · 2017-11-29 · Zimmer Biomet - Syngo.plaza, Picture Archiving and Communications System(PACS), Model 10863171 Syngo.plaza is a Picture Archiving and Communication System…
FDA Device · Class II · 2017-11-29 · Siemens Medical Solutions Usa - MEDLINE DOUBLE SWIVEL CLOSED SUCTION CATHETER, 21.3 in (54 cm) FOR ENDOTRACHEAL TUBE, 12 Fr, REF DYNCSDS12, 1 Each, Sterile
FDA Device · Class II · 2017-11-29 · Medline Industries - Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health - Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems
FDA Device · Class II · 2017-11-29 · Abbott Laboratories - Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health - Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box
FDA Device · Class II · 2017-11-29 · Medline Industries - Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health - Sensicare Green Surgical Glove, PI, LF, PF. Packaged in a poly/poly peel pouch with Sunoco films, sterile
FDA Device · Class II · 2017-11-29 · Medline Industries - Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - ROSA BRAIN 3.0.0
FDA Device · Class II · 2017-11-29 · Zimmer Biomet - Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
FDA Device · Class II · 2017-11-29 · Medtronic - Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX.
FDA Device · Class II · 2017-11-29 · Exactech - Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health - Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Device · Class II · 2017-11-29 · Medtronic - ARCHITECT c4000 part number 02P24
FDA Device · Class II · 2017-11-29 · Abbott Laboratories - ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to gui…
FDA Device · Class II · 2017-11-29 · Zimmer Biomet - Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
FDA Device · Class II · 2017-11-29 · Medtronic - Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX.
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8
FDA Device · Class II · 2017-11-29 · Medline Industries - Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and upgrade kit 050-9043-00 Rev G. The Spacelabs Arkon Anesthesia…
FDA Device · Class I · 2017-11-29 · Spacelabs Healthcare - Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health - Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments
FDA Device · Class II · 2017-11-29 · Zimmer Biomet - Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12 vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health - Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health - Medtronic MiniMed(TM) Mio(TM) (MMT-921, 921T, 923, 923T, 925, 925T, 941, 941T, 943, 943T, 945, 945T, 961, 963, 963T, 965, 965T, 975, 975T)
FDA Device · Class II · 2017-11-29 · Medtronic - ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used…
FDA Device · Class II · 2017-11-29 · Zimmer Biomet - SURPLUG MICRO CONNECTOR Item No. 066-C3352
FDA Device · Class II · 2017-11-29 · Icu Medical - Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits per case
FDA Device · Class II · 2017-11-29 · Halyard Health - Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument hol…
FDA Device · Class II · 2017-11-29 · Zimmer Biomet - Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000
FDA Device · Class II · 2017-11-29 · Shippert Medical Technologies - Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box
FDA Device · Class II · 2017-11-29 · Medline Industries - Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - 3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
FDA Device · Class II · 2017-11-29 · 3m Health Care Business - Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX
FDA Device · Class II · 2017-11-29 · Exactech - ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm
FDA Device · Class II · 2017-11-22 · Zimmer Biomet - STORZ High Flow Insufflation Tubing (with filter), Catalog #20400161S/10 (outer box label), ENDOFLATOR 26-430520-1 also referenced on outer…
FDA Device · Class II · 2017-11-22 · Karl Storz Endoscopy - HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Device · Class II · 2017-11-22 · Terumo Bct - ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument ho…
FDA Device · Class II · 2017-11-22 · Zimmer Biomet - iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL…
FDA Device · Class II · 2017-11-22 · Arthrex - ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm
FDA Device · Class II · 2017-11-22 · Zimmer Biomet - ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm
FDA Device · Class II · 2017-11-22 · Zimmer Biomet - smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System…
FDA Device · Class II · 2017-11-22 · Smith And Nephew - HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Device · Class II · 2017-11-22 · Terumo Bct - Symbia Intevo 6, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or o…
FDA Device · Class II · 2017-11-22 · Siemens Medical Solutions Usa - smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
FDA Device · Class II · 2017-11-22 · Smith And Nephew - Plum 360 Infusion System, List number 30010
FDA Device · Class II · 2017-11-22 · Icu Medical - Symbia Intevo 16, SPECT/CT System, Emission Computed Tomography System To detect or image the distribution of radionuclides in the body or…
FDA Device · Class II · 2017-11-22 · Siemens Medical Solutions Usa - Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Part…
FDA Device · Class II · 2017-11-22 · Walkmed - AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx. The firm name on the label is Beckman Coulter Ireland Inc., Ireland
FDA Device · Class II · 2017-11-22 · Beckman Coulter - MOMENTUM X4 CRT-D, Model G138, Sterile
FDA Device · Class II · 2017-11-15 · Boston Scientific - RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For…
FDA Device · Class II · 2017-11-15 · Epimed International - RESONATE X4 CRT-D, Model G447, Sterile
FDA Device · Class II · 2017-11-15 · Boston Scientific - Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee
FDA Device · Class II · 2017-11-15 · Zimmer Biomet - RESONATE EL ICD VR, Model D432, Sterile
FDA Device · Class II · 2017-11-15 · Boston Scientific - VITEK2 GP-ID, REF 21342 IVD
FDA Device · Class II · 2017-11-15 · Biomerieux - RESONATE EL ICD DR, Model D433, Sterile
FDA Device · Class II · 2017-11-15 · Boston Scientific - HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO Harvest Graph Delivery System is a disposable pack that takes…
FDA Device · Class II · 2017-11-15 · Terumo Bct - AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO
FDA Device · Class II · 2017-11-15 · Windstone Medical Packaging - Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
FDA Device · Class II · 2017-11-15 · Limacorporate S P A
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