21 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED3511, FRED5014, FRED3516, MV-F451827; FRED X 27, REF: XFRED4017-MVE, XFRED4528-MVE, MV-F501427X, XFRED4518-MVE, XFRED5526-MVE, XFRED4539-MVE, FREDX5522-PMA, FREDX3522-PMA, FREDX4525-PMA, FREDX5015-PMA, FREDX5532-PMA, FREDX4013-PMA, FREDX3513-PMA, FREDX4515-PMA, FREDX3517-PMA, MV-F352427X
FDA Recall
Open, Classified
·MICROVENTION INC.·Product code OUT·September 5, 2025
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
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
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
The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to increase lubricity. The AOMC is designed to facilitate catheter retrieval in the event the catheter becomes entrapped within the vasculature. The distal section of the catheter incorporates a detachment zone that allows detachment of the distal tip when the force required to extract the catheter exceeds the force to detach the tip. The catheter has two radiopaque marker bands to visualize the position of the catheter and the detach zone area, one proximal to the detach zone and one at the distal end of the catheter.
FDA Recall
Open, Classified
·Micro Therapeutics, Inc.·Product code MFE·January 11, 2024
The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard Luer adapter to facilitate the attachment of accessories. The outer diameter surface of the catheter is hydrophilically coated to increase lubricity. The AOMC is designed to facilitate catheter retrieval in the event the catheter becomes entrapped within the vasculature. The distal section of the catheter incorporates a detachment zone that allows detachment of the distal tip when the force required to extract the catheter exceeds the force to detach the tip. The catheter has two radiopaque marker bands to visualize the position of the catheter and the detach zone area, one proximal to the detach zone and one at the distal end of the catheter.
FDA Recall
Open, Classified
·Micro Therapeutics, Inc.·Product code MFE·January 11, 2024
Bodor P and C series laser cutting machines
FDA Recall
Open, Classified
·Jinan Bodor Cnc Machine Co Ltd NO.1299, XINLUO AVE HI-TECH ZONE Jinan China·Product code RFE·December 19, 2024
Bodor's I series laser cutting machine.
FDA Recall
Open, Classified
·Jinan Bodor Cnc Machine Co Ltd NO.1299, XINLUO AVE HI-TECH ZONE Jinan China·Product code RFE·February 7, 2025