Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - Product Usage: ...
Medical Devices·110 affected·Apr 23, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray Syste...
Medical Devices·5 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit. REF/UDI / 94124/10859821006480 - Product Usage: is...
Medical Devices·120 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: i...
Medical Devices·6,254 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit. REF/UDI / 94115/10859821006251 - Product Usage: is us...
Medical Devices·50 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit. REF/UDI / 94114/10859821006220 - Product Usage: is use...
Medical Devices·30 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is use...
Medical Devices·2,697 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - Product Usage: is us...
Medical Devices·6 affected·Apr 23, 2020
High RiskFDA
Olympus Corporation Of The Americas
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Medical Devices·18 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit. REF/UDI / 94104/10859821006169 - Product Usage: is use...
Medical Devices·7,395 affected·Apr 23, 2020
High RiskFDA
Access Scientific Llc
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit. REF/UDI / 94106/10859821006176 - Product Usage: ...
Medical Devices·1,864 affected·Apr 23, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to pro...
Medical Devices·16 affected·Apr 20, 2020
High RiskFDA
Cardinal Health Inc.
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all ...
Medical Devices·0 affected·Apr 20, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to prov...
Medical Devices·4 affected·Apr 20, 2020
High RiskFDA
Suntech Medical, Inc.
Oscar 2, Model 250 System
Medical Devices·1,037 affected·Apr 20, 2020
High RiskFDA
Roi Cps Llc
Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.
Medical Devices·40 affected·Apr 20, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a...
Medical Devices·4,065 affected·Apr 17, 2020
High RiskFDA
Alcon Research Llc
Acrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE LENS, w/UltraSert DELIVERY SYSTEM, UV w/BLUE LIG...
Medical Devices·84 affected·Apr 17, 2020
High RiskFDA
Siemens Medical Solutions Usa, Inc
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194
Medical Devices·20 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArCo...
Medical Devices·122 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 6...
Medical Devices·46 affected·Apr 17, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Sys...
Medical Devices·2,361,885 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial...
Medical Devices·107 affected·Apr 17, 2020
High RiskFDA
Biomet, Inc.
Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip S...
Medical Devices·58 affected·Apr 17, 2020
High RiskFDA
Baxter Healthcare Corporation
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatmen...
Medical Devices·53,895 affected·Apr 17, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Right, Sterile, Catalog # 504-02-54C-R, UDI (01)07613327012415(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 left, Sterile, Catalog # 504-02-64E-L, UDI (01)07613327012484(17)
Medical Devices·0 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Right, Sterile, Catalog # 504-02-56D-R, UDI (01)07613327012347(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 54 Left, Sterile, Catalog # 504-02-54C-L, UDI (01)07613327012354(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 right, Sterile, Catalog # 504-02-60D-R, UDI (01)07613327012408(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 right, Sterile, Catalog # 504-02-62E-R, UDI (01)07613327012439(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 60 Left, Sterile, Catalog # 504-02-60D-L, UDI (01)07613327012422(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 56 Left, Sterile, Catalog # 504-02-56D-L, UDI (01)07613327012361(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Becton Dickinson & Company
BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535
Medical Devices·16,099,310 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 62 left, Sterile, Catalog # 504-02-62E-L, UDI (01)07613327012453(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 64 right, Sterile, Catalog # 504-02-64E-R, UDI (01)07613327012460(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Howmedica Osteonics Corp.
Stryker Orthopaedics-Restoration Anatomic Hemispherical Shell, Size 58 Left, Sterile, Catalog # 504-02-58D-L, UDI (01)07613327012385(17)
Medical Devices·4,895 affected·Apr 16, 2020
High RiskFDA
Ivoclar Vivadent Ag
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxi...
Medical Devices·6 affected·Apr 13, 2020
High RiskFDA
Ivoclar Vivadent Ag
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide...
Medical Devices·332 affected·Apr 13, 2020
High RiskFDA
Ivoclar Vivadent Ag
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxid...
Medical Devices·639 affected·Apr 13, 2020
High RiskFDA
Bd Switzerland Sarl
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Micro...
Medical Devices·110,350 affected·Apr 9, 2020
High RiskFDA
Bd Switzerland Sarl
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product U...
Medical Devices·110,350 affected·Apr 9, 2020
High RiskFDA
Bd Switzerland Sarl
BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 10800177 - Product Usage: Micro...
Medical Devices·110,350 affected·Apr 9, 2020
High RiskFDA
Wright Medical Technology Inc
WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by...
Medical Devices·22 affected·Apr 9, 2020
High RiskFDA
Qiagen Sciences Llc
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Medical Devices·530 affected·Apr 8, 2020
High RiskFDA
Inpeco S.a.
Abbott Accelerator a3600 Centrifuge Module tube loading algorithm, Inpeco SA P/N: FLX-202, with Firmware Versions: CM_1-7-0.H86 or xCMd_2...
Medical Devices·23 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-3 Branch, Product Code: M00202175912P0 - Product Usage: for use in the replacement...
Medical Devices·0 affected·Apr 7, 2020
High RiskFDA
Maquet Cardiovascular, Llc
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - Product Usage: for use in the replacement...
Medical Devices·0 affected·Apr 7, 2020