24 results
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20ms
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Sources: EU EUDAMED, US FDA
Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.
FDA Recall
Open, Classified
·Biocartis Nv B 3 Generaal De Wittelaan 11 Mechelen Belgium·Product code OOI·December 10, 2024
AVE 2 Birthing Bed - Product Usage: is designated to be used by mothers ready for spontaneous vaginal delivery and also as aid to search for individual positions providing relief in all delivery stages including postpartum period. Birthing bed is not intended for use as a general hospital bed.
FDA Recall
Open, Classified
·Linet Americas·Product code HDD·March 6, 2020
EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
FDA Recall
Open, Classified
·Ortho8, Inc.·Product code JOW·July 9, 2021
Brand Name: Canturio Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio Smart Extension (CSE) is a tibial implant component intended for use with the Zimmer Persona Personalized Knee System.
FDA Recall
Open, Classified
·Canary Medical, Inc.·Product code QPP·May 2, 2025
NelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66T
FDA Recall
Open, Classified
·Nelson Innovaions, Llc·Product code NAE·February 11, 2020
Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code NBE·December 6, 2023
Baxter Preveleak Surgical Sealant, Product Codes: ADS201808
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code NBE·December 6, 2023
PREGNANCY TEST 24CT
FDA Recall
Open, Classified
·GOLD STAR DISTRIBUTION INC·Product code LCX·December 26, 2025
Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019
B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.
FDA Recall
Open, Classified
·Braxton Medical Corporation·Product code FOZ·September 4, 2020
Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019
Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517
FDA Recall
Open, Classified
·Medtronic Navigation, Inc.·Product code HAW·October 30, 2019
Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT
FDA Recall
Open, Classified
·GOLD STAR DISTRIBUTION INC·Product code KGX·December 26, 2025
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct.
FDA Recall
Open, Classified
·GOLD STAR DISTRIBUTION INC·Product code EFW·December 26, 2025
ViewPoint; system, imaging processing, radiological
FDA Recall
Open, Classified
·GE Healthcare GmbH Oskar-Schlemmer-Str. 11 Munich Germany·Product code LLZ·August 8, 2024
Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
FDA Recall
Open, Classified
·Pivotal Health Solutions, Inc.·Product code ITH·April 29, 2024
Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, ALWAYS THIN LINERS UNSCENTED 12 CT, ALWAYS THIN LINERS SCENTED 12CT, ALWAYS ULT.THIN WINGS REG.12/22CT, ALWAYS ULT.THIN OVER NIGHT WINGS 12/16CT, JULIE MAXI NIGHT W.WINGS 36/10CT, STAY FREE REG. 12/10CT, STAY FREE SUPER 24/6CT, TAMPAX REG. 10CT, TAMPAX SUPER 10CT.
FDA Recall
Open, Classified
·GOLD STAR DISTRIBUTION INC·Product code HEB·December 26, 2025
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
FDA Recall
Open, Classified
·GE Healthcare GmbH Oskar-Schlemmer-Str. 11 Munich Germany·Product code LLZ·August 8, 2024
Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CONDOMS 6/DSP LITE BLUE, TROJAN SPERMICIDE CONDOMS 6/DSP DARK BLUE, TROJAN ULTRA THIN CONDOMS 6/DSP GREY, TROJAN RIBBED CONDOMS 6/DSP GOLD/BROWN, TROJAN NONLUBRICATED CONDOMS 6/DSP RED, TROJAN ULTRA HER PLEASURE CONDOMS 6/DSP, TROJAN CONDOMS MAGNUM 48 CT DISP, *BOX TROJAN CONDOMS MAGNUM 50CT .
FDA Recall
Open, Classified
·GOLD STAR DISTRIBUTION INC·Product code HIS·December 26, 2025
Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.
FDA Recall
Open, Classified
·Augmedics Ltd. 2 Ha-Otsma St Yokneam Illit Northern Israel·Product code OLO·April 14, 2025