Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 104 of 548
FDA Devices Moderate Sep 20, 2023
50-GEL20; Ultrasound gel
Advance Medical Designs, Inc.
FDA Devices Critical Sep 20, 2023
Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be…
Abbott Medical
FDA Devices Moderate Sep 20, 2023
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18120-000; b) 18120-KIT; c) 18120-SET; radiation monitoring dosimeter used with the microS…
Landauer
FDA Devices Moderate Sep 20, 2023
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Advance Medical Designs, Inc.
FDA Devices Moderate Sep 20, 2023
nanoDot D2DNS, for custom calibrate, OTO, Model Numbers 03034-OTO; radiation monitoring dosimeter used with the microSTAR readers
Landauer
FDA Devices Moderate Sep 20, 2023
nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers
Landauer
FDA Devices Moderate Sep 20, 2023
nanoDot D2DNS, for custom calibrate, OTO, Model Number 03033-OTO; radiation monitoring dosimeter used with the microSTAR readers
Landauer
FDA Devices Critical Sep 20, 2023
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
MEDLINE INDUSTRIES, LP - Northfield
FDA Devices Moderate Sep 20, 2023
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 04225-000 (EMEA number VINLNAN005); b) 04225-KIT; c) 04225-SET; radiation monitoring dosimeter us…
Landauer
FDA Devices Moderate Sep 20, 2023
nanoDot D2DNN, Model Numbers: a) 03053-1MO; b) 03053-1WK ; c) 03053-3MO; d) 03053-OTO; e) 03053-SMO; radiation monitoring dosimeter used w…
Landauer
FDA Devices Moderate Sep 20, 2023
Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Sep 20, 2023
ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testin…
Instrumentation Laboratory
FDA Devices Moderate Sep 20, 2023
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
BioFire Diagnostics, LLC
FDA Devices Moderate Sep 20, 2023
nanoDot D2DNN, Model Numbers: a) 18105-000; b) 18105-KIT; radiation monitoring dosimeter used with the microSTAR readers
Landauer
FDA Devices Moderate Sep 20, 2023
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
Siemens Medical Solutions USA, Inc.
FDA Devices Moderate Sep 20, 2023
BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are affected when a relative calibration is performed using ArrayCal (module …
PTW-FREIBURG
FDA Devices Moderate Sep 20, 2023
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18130-000; b) 18130-KIT; c) 18130-SET; radiation monitoring dosimeter used with the microSTAR rea…
Landauer
FDA Devices Moderate Sep 20, 2023
nanoDot D2DNS, Model Numbers: a) 03056-000 (EMEA number VINLNAN002); b) 03056-1MO; c) 03056-3MO; d) 03056-KIT; radiation monitoring dosimet…
Landauer
FDA Devices Moderate Sep 20, 2023
QC (Cs-137) screened nanoDot D2DNS, Model Number 03067-OTO; radiation monitoring dosimeter used with the microSTAR readers
Landauer
FDA Devices Moderate Sep 20, 2023
Welch Allyn Connex Spot Monitor
Baxter Healthcare Corporation
FDA Devices Moderate Sep 20, 2023
NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
Landauer
FDA Devices Moderate Sep 20, 2023
Constancy (Cs-137) nanoDot D2DNN, Model Numbers: a) 18155-000 (EMEA number VKITCON001); b) 18155-KIT; radiation monitoring dosimeter used with t…
Landauer
FDA Devices Moderate Sep 20, 2023
Calibrate (Cs-137) screened nanoDot D2DNS, Model Number 03065-OTO; radiation monitoring dosimeter used with the microSTAR readers
Landauer
FDA Devices Moderate Sep 20, 2023
nanoDot D2DXS, Model Numbers: a) 03063-1MO; b) 03063-3MO; c) 03063-OTO; d) 03063-SMO; radiation monitoring dosimeter used with the microSTAR…
Landauer
FDA Devices Moderate Sep 20, 2023
Calibrate (80 kVp) screened nanoDot D2DNS, Model Number 03064-OTO; radiation monitoring dosimeter used with the microSTAR readers
Landauer
FDA Devices Moderate Sep 20, 2023
QC (Cs-137) nanoDot D2DNS, Model Numbers: a) 18135-000; b) 18135-KIT; c) 18135-SET; radiation monitoring dosimeter used with the microSTAR rea…
Landauer
FDA Devices Moderate Sep 20, 2023
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
Advance Medical Designs, Inc.
FDA Devices Moderate Sep 20, 2023
Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to protect ag…
Keystone Industries
FDA Devices Moderate Sep 20, 2023
nanoDot D2DXN, Model Numbers: a) 03061-1MO; b) 03061-3MO; c) 03061-OTO; d) 03061-SMO; radiation monitoring dosimeter used with the microSTAR…
Landauer
FDA Devices Moderate Sep 20, 2023
Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.
Medtronic Sofamor Danek USA Inc
FDA Devices Moderate Sep 20, 2023
nanoDot B - item 2 of 3 for 03500-000, Model Number 03502-000; radiation monitoring dosimeter used with the microSTAR readers
Landauer
FDA Devices Moderate Sep 20, 2023
Calibrate (80 kVp) nanoDot D2DNS, Model Numbers: a) 18121-000; b)18121-KIT; c) 18121-SET; radiation monitoring dosimeter used with the microST…
Landauer
FDA Devices Moderate Sep 20, 2023
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f…
Advance Medical Designs, Inc.
FDA Devices Moderate Sep 20, 2023
nanoDot D2DXS, Model Numbers: a) 03062-1MO; b) 03062-3MO; c) 03062-OTO; d) 03062-SMO; radiation monitoring dosimeter used with the microSTAR…
Landauer
FDA Devices Moderate Sep 20, 2023
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Keystone Industries
FDA Devices Moderate Sep 20, 2023
QC (80 kVp) nanoDot D2DNS, Model Numbers: a) 18131-000; b) 18131-KIT; c) 18131-SET; radiation monitoring dosimeter used with the microSTAR rea…
Landauer
FDA Devices Moderate Sep 20, 2023
nanoDot C - item 3 of 3 for 03500-000, Model Number 03503-000; radiation monitoring dosimeter used with the microSTAR readers
Landauer
FDA Devices Moderate Sep 13, 2023
ISee Ortho-K Lens
PARAGON VISION SCIENCES, Inc
FDA Devices Moderate Sep 13, 2023
Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-…
Aomori Olympus Co., Ltd.
FDA Devices Moderate Sep 13, 2023
Allura Xper series
Philips Medical Systems Nederland B.V.
FDA Devices Moderate Sep 13, 2023
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Zimmer, Inc.
FDA Devices Low Sep 13, 2023
ZVU Functional GI Software, REF: ZVU-3
Diversatek Healthcare
FDA Devices Moderate Sep 13, 2023
Azurion
Philips Medical Systems Nederland B.V.
FDA Devices Moderate Sep 13, 2023
Fargo Ortho-K Lens
PARAGON VISION SCIENCES, Inc
FDA Devices Moderate Sep 13, 2023
3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000
Philips Ultrasound, Inc.
CPSC Moderate Sep 7, 2023
Emporia Recalls North America Smart Plugs Due to Electric Shock Hazard
FDA Drug Moderate Sep 6, 2023
PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC…
Central Admixture Pharmacy Services, Inc.
FDA Devices Moderate Sep 6, 2023
Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
Olympus Corporation of the Americas
FDA Devices Moderate Sep 6, 2023
epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
Siemens Healthcare Diagnostics Inc
FDA Devices Critical Sep 6, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33…
Datascope Corp.