Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 223 of 548
FDA Devices Moderate Apr 1, 2020
LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-…
Abbott Gmbh & Co. KG
FDA Devices Moderate Apr 1, 2020
BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter, Ref: 0604550, UDI: (01)00801741025860 Prod…
Bard Peripheral Vascular Inc
FDA Devices Moderate Apr 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
Medtronic MiniMed
FDA Devices Moderate Apr 1, 2020
1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port…
Bard Peripheral Vascular Inc
FDA Devices Moderate Apr 1, 2020
Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device…
Dexcom Inc
FDA Devices Moderate Apr 1, 2020
iChemVELOCITY Strips, Catalog 800-7212
Beckman Coulter, Inc.
FDA Devices Moderate Apr 1, 2020
PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00801741129438…
Bard Peripheral Vascular Inc
FDA Devices Moderate Apr 1, 2020
MiniMed Insulin Pump, model # MMT-508
Medtronic MiniMed
FDA Devices Moderate Apr 1, 2020
Dexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicate…
Dexcom Inc
FDA Devices Moderate Apr 1, 2020
Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
MEDTRONIC ATS MEDICAL, INC.
FDA Devices Moderate Apr 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
Medtronic MiniMed
FDA Devices Moderate Apr 1, 2020
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-…
Insulet Corporation
FDA Devices Moderate Apr 1, 2020
Karl Storz NEURO-FIBERSCOPE, Model # 11282BN1, Flexible Pediatric Neuroscope
Karl Storz Endoscopy
FDA Devices Moderate Apr 1, 2020
Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the qualit…
Randox Laboratories Ltd.
FDA Devices Moderate Apr 1, 2020
Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754
Medtronic MiniMed
FDA Devices Moderate Apr 1, 2020
Quidel Triage TOX Drug Screen Control 1 Kit Box containing 5 Control 1 vials with 5 x 0.25 mL vials per box. Quidel Cardiovascular Inc. 9975 Su…
QUIDEL CARDIOVASCULAR INC
FDA Devices Moderate Apr 1, 2020
MiniMed Paradigm 512 Insulin pump
Medtronic MiniMed
FDA Devices Moderate Apr 1, 2020
ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage: ADVIA TBIL_2 is for in vitro diagnostic use i…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 1, 2020
BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 Product Usage: B…
Bard Peripheral Vascular Inc
FDA Devices Moderate Apr 1, 2020
BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563 Product Usa…
Bard Peripheral Vascular Inc
FDA Devices Moderate Apr 1, 2020
LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
Carroll-Baccari, Inc.
FDA Devices Moderate Apr 1, 2020
MiniMed Paradigm Insulin pump, model number MMT-712
Medtronic MiniMed
FDA Devices Moderate Apr 1, 2020
FlipCutter III Drill
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
FDA Devices Moderate Apr 1, 2020
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: D…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 1, 2020
RayStation standalone software treatment planning system, Model Numbers 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, 9.1 - Product Usage: RaySta…
RAYSEARCH LABORATORIES AB
FDA Devices Moderate Apr 1, 2020
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 ass…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
Medtronic MiniMed
FDA Devices Moderate Apr 1, 2020
MiniMed Paradigm Model 511 Insulin Pump
Medtronic MiniMed
FDA Devices Moderate Apr 1, 2020
Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653
Abbott Diabetes Care, Inc.
FDA Devices Moderate Apr 1, 2020
1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, UDI: (01)008…
Bard Peripheral Vascular Inc
FDA Devices Moderate Apr 1, 2020
Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
Medtronic MiniMed
FDA Devices Moderate Apr 1, 2020
Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
Medline Industries Inc
FDA Devices Moderate Apr 1, 2020
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and del…
Elekta Impac Software
FDA Devices Moderate Apr 1, 2020
Honeywell Pressure Transducer- Part Number: 370506-22. It is a component used in 2008T, Common Name: Hemodialysis Delivery System; 2008T HD SYS. BLUE…
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Apr 1, 2020
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 1, 2020
1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)008017410…
Bard Peripheral Vascular Inc
FDA Devices Moderate Mar 25, 2020
Integris Allura 9, system codes 722018 722021
Philips North America, LLC
FDA Devices Moderate Mar 25, 2020
Cardio Vascular-Allura Centron, system code 722400
Philips North America, LLC
FDA Devices Moderate Mar 25, 2020
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
FDA Devices Moderate Mar 25, 2020
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multip…
Avid Medical, Inc.
FDA Devices Moderate Mar 25, 2020
IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) and OUS: L2KE22 (200 tests), L2KE26 (600 tests) - P…
Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Mar 25, 2020
AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tom…
Agfa N.V.
FDA Devices Moderate Mar 25, 2020
OsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 359100, Dimensions: ONE(1) PACKAGE - CONTAINING 10.0c…
XTANT MEDICAL INC
FDA Devices Moderate Mar 25, 2020
Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: Artis is a fa…
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Mar 25, 2020
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a pa…
LivaNova USA Inc.
FDA Devices Moderate Mar 25, 2020
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multip…
Avid Medical, Inc.
FDA Devices Moderate Mar 25, 2020
UroDiagnost Eleva, system code 708033
Philips North America, LLC
FDA Devices Moderate Mar 25, 2020
TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
Materialise N.V.
FDA Devices Moderate Mar 25, 2020
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multip…
Avid Medical, Inc.
FDA Devices Moderate Mar 25, 2020
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K…
Aesculap Implant Systems LLC