FDA Device · 2019
FDA Device recalls in 2019
RecallRadar indexes 2,801 FDA Device recall notices published in 2019. By classification: 369 Class I, 2,343 Class II, 89 Class III.
- BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
FDA Device · Class II · 2019-10-16 · Becton Dickinson And - Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
FDA Device · Class II · 2019-10-16 · Horiba Instruments - cobas c 311
FDA Device · Class II · 2019-10-16 · Roche Diagnostics Operations - BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes
FDA Device · Class II · 2019-10-16 · Becton Dickinson And Bd Biosciences - BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes
FDA Device · Class II · 2019-10-16 · Becton Dickinson And Bd Biosciences - CENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - Centurion CIRCLAMP W/1.3 CM BELL-single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a male…
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonster…
FDA Device · Class II · 2019-10-16 · Trimed - STERILE CAP CHANGE KIT DYNDC1946B
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - CVC BUNDLE, 20CM, 3L, PI ECVC5120A
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - NEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE
FDA Device · Class II · 2019-10-16 · Leica Biosystems Imaging - STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
FDA Device · Class II · 2019-10-16 · Ethicon - CVC BUNDLE VANTEX 7F, 3L, 20CM ECVC6065
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - TRIPLE LUMEN BUNDLE KIT ECVC1540
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - INVASIVE PROCEDURE TRAY MNS9510
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack)
FDA Device · Class II · 2019-10-16 · Aziyo Biologics - Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage
FDA Device · Class II · 2019-10-16 · Arrow International - BD Microtainer SST- Amber Part/Catalog Number: 365978
FDA Device · Class II · 2019-10-16 · Becton Dickinson And - K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments incl…
FDA Device · Class II · 2019-10-16 · K2m - CVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, m…
FDA Device · Class II · 2019-10-16 · Vital Scientific N V - PEDIATRIC PICC INSERTION TRAY CVI4450A
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA 3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm…
FDA Device · Class II · 2019-10-16 · K2m - IV START KIT IV8440
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes
FDA Device · Class II · 2019-10-16 · Becton Dickinson And Bd Biosciences - Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
FDA Device · Class II · 2019-10-16 · Roche Diagnostics Operations - INFUSA PORT KIT DYNDC1840E
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - PICC Line Accessory Kit CVI4285
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - BD Microtainer SST Part/Catalog No.365967
FDA Device · Class II · 2019-10-16 · Becton Dickinson And - CENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545A
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - VANTEX 7FR, 16CM, 3L CVC BUNDLE ECVC6670
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - Centurion CIRCLAMP W/1.1CM BELL - single-use, disposable instrument used to compress the foreskin of the penis during circumcision of a mal…
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - Cap Change Kit DT20310
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - IV KIT - SORBAVIEW IVS3475
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
FDA Device · Class II · 2019-10-16 · Becton Dickinson And - BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
FDA Device · Class II · 2019-10-16 · Becton Dickinson And - BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
FDA Device · Class II · 2019-10-16 · Becton Dickinson And - CENTRAL LINE BUNDLE ECVC6375
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - Giraffe Omnibed - Product Usage: The OmniBed is a combination of an infant incubator and an infant warmer
FDA Device · Class II · 2019-10-16 · Ohmeda Medical - INFUSA PORT KIT DYNDC1840F
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - CVC BUNDLE MULTIMED, 3L, 20CM ECVC6060
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - CAP BUNDLE KIT DYNDC2137
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - CVC BUNDLE, 20CM, 3L, PI ECVC5120
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - CVC BUNDLE WITHOUT CATH CVI4600
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes
FDA Device · Class II · 2019-10-16 · Becton Dickinson And Bd Biosciences - SPIFE ImmunoFix-6 Kit, Cat
FDA Device · Class II · 2019-10-16 · Helena Laboratories - BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes
FDA Device · Class II · 2019-10-16 · Becton Dickinson And Bd Biosciences - Achilles Insight Bone Sonometer
FDA Device · Class II · 2019-10-16 · Ge Healthcare - BioEnvelope, surgical mesh envelope
FDA Device · Class II · 2019-10-16 · Aziyo Biologics - Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
FDA Device · Class II · 2019-10-16 · Roche Diagnostics Operations - CAP CHANGE KIT DYNDC1496B
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - PEDIATRIC PICC INSERTION TRAY CVI4450
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes
FDA Device · Class II · 2019-10-16 · Becton Dickinson And Bd Biosciences - PORT AND IO ACCESS DRESSING KIT DT15780A
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes
FDA Device · Class II · 2019-10-16 · Becton Dickinson And Bd Biosciences - iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
FDA Device · Class II · 2019-10-16 · Conformis - BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
FDA Device · Class II · 2019-10-16 · Becton Dickinson And Bd Biosciences - iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
FDA Device · Class II · 2019-10-16 · Conformis - AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determi…
FDA Device · Class II · 2019-10-16 · Roche Diagnostics Operations - CVC BUNDLE, 20CM, 4L, PI ECVC5095
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - 20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets" Product # RMS22606 - Product Usage: RMS HlgH-Flo Subcutaneous Safety Ne…
FDA Device · Class II · 2019-10-16 · Repro Med Systems - BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
FDA Device · Class II · 2019-10-16 · Becton Dickinson And Bd Biosciences - cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
FDA Device · Class II · 2019-10-16 · Roche Diagnostics Operations - CVC INSERTION BUNDLE 8.5FR 4L 16CM ECVC6355
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - Neonatal Cap Change Kit DT20315
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - OR VANTEX 7FR 3L 16CM CVC ECVC6665
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
FDA Device · Class II · 2019-10-16 · Ethicon - UVC TRAY UVT875
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696, a receive-only RF coil designed for use with GE 3.…
FDA Device · Class II · 2019-10-16 · Ge Healthcare - IV SECUREMENT KIT IVS3405
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
FDA Device · Class II · 2019-10-16 · Becton Dickinson And - TRIPLE LUMEN CVC 20CM BUNDLE STCVC2040
FDA Device · Class II · 2019-10-16 · Centurion Medical Products - BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog Number: 365987
FDA Device · Class II · 2019-10-16 · Becton Dickinson And - Stryker Neurovascular, Merci 9F, 80cm, Balloon Guide Catheter, REF 90077, CE 0459, UPN Product No. 90077, UDI #: (01)00815742000771
FDA Device · Class II · 2019-10-16 · Stryker Neurovascular - Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
FDA Device · Class II · 2019-10-09 · Merit Medical Systems - SHERPA NX ACTIVE GUIDING CATHETER, 6F AL.75 SH, .070", REF SA6AL75SH. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 90CM, 070", REF SA6IMAD . for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP3.5, .070", REF SA6CHAMP35. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F, MPH, 55CM, 070", REF SA6MPHK. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
FDA Device · Class II · 2019-10-09 · Inter Med - SHERPA NX ACTIVE GUIDING CATHETER, 6F SAL2.0, .070", REF SA6SAL20. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F, EBU3.5, 90CM.070", REF SA6EBU35D. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F JR4.0 SH, .070", REF SA6JR40SH. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F RCB SH, .070", REF SA6RCBSH. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.75, .070", REF SA6EBU375. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F JL5.0, .070", REF SA6JL50. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5, .070", REF SA6EBU35. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinic…
FDA Device · Class III · 2019-10-09 · Elitech Group B V - SHERPA NX ACTIVE GUIDING CATHETER, 6F HSII SH, .070", REF SA6HSIISH. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F ECR3.5 SH, .070", REF SA6ECR35SH. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F CHAMP2.0 SH, .070", REF SA6CHAMP20SH. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829
FDA Device · Class II · 2019-10-09 · Quality Electrodynamics - SHERPA NX ACTIVE GUIDING CATHETER, 6F, RCB, 90CM, 070", REF SA6RCBD. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F SCR4.0, .070", REF SA6SCR40. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - SHERPA NX ACTIVE GUIDING CATHETER, 6F EL GAMAL, .070", REF SA6ELGAMAL. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular - Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Freq…
FDA Device · Class III · 2019-10-09 · Coopersurgical - C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: The C2 Nerve Monitor System is intended for intra-operative mo…
FDA Device · Class II · 2019-10-09 · Stryker Instruments Div - SHERPA NX ACTIVE GUIDING CATHETER, 6F, SR4.0, 100CM, 070", REF SA6SR40. for cardiovascular use
FDA Device · Class I · 2019-10-09 · Medtronic Vascular
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