327 results · 17ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

BostonSight SCLERAL Lens

FDA Recall
Open, Classified ·Boston Foundation For Sight·Product code HQD·June 10, 2025

BostonSight PROSE Lens.

FDA Recall
Open, Classified ·Boston Foundation For Sight·Product code HQD·June 10, 2025

MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";

FDA Recall
Open, Classified ·Aesculap Inc·Product code HCF·December 29, 2023

Cepheid Xpert SA Nasal Complete Control Panel (Catalog #8196) UDI: 70845357041233 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

FDA Recall
Open, Classified ·Microbiologics Inc·Product code PMN·April 9, 2019

Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand.

FDA Recall
Open, Classified ·Microbiologics Inc·Product code PMN·April 9, 2019

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

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE HEGAR DILATOR 5&6MM STERL CS25Model Number 96-0963; 5) ECONO STERILE HEGAR DILATOR 3&4MM STERL CS25Model Number 96-0964; 6) ECONO STERILE HEGAR DILATOR 1&2MM STERL CS25Model Number 96-0965; 7) ECONO STERILE HANK DILATOR 5.5&6MM STRL CS25Model Number 96-0966; gynecological dilators

FDA Recall
Open, Classified ·Sklar Instruments·Product code HDQ·December 3, 2024

Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERILE, Product Code HUD910ST; e) HANK UTERINE DILATOR 11" 7/8FR STERILE, Product Code I68920; f) HANK UTERINE DILATOR 11" 13/14FR STERILE, Product Code I68930

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code HDQ·February 23, 2024

Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories. Note: U1053617 added 1/29/2021 after noticing it had been inadvertently left off

FDA Recall
Open, Classified ·Respironics California, LLC·Product code MNT·November 2, 2020

UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis

FDA Recall
Open, Classified ·Beckman Coulter, Inc.·Product code KQO·April 5, 2023

DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis

FDA Recall
Open, Classified ·Beckman Coulter, Inc.·Product code KQO·April 5, 2023

DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis

FDA Recall
Open, Classified ·Beckman Coulter, Inc.·Product code KQO·April 5, 2023

iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagnostic device, urine analysis, c) iQ200 Select 1500, Part Number 700-3347, d) iQ200 Sprint, Part Number 700-3325

FDA Recall
Open, Classified ·Beckman Coulter, Inc.·Product code KQO·April 5, 2023

VADER pedicle system, torque wrench, Catalog Number 42-703

FDA Recall
Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code PML·November 28, 2023

VADER pedicle system, torque wrench, Catalog Number 42-702

FDA Recall
Open, Classified ·Icotec Ag Industriestrasse 12 Altstatten Sg Switzerland·Product code PML·November 28, 2023

Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile

FDA Recall
Open, Classified ·Cook Biotech, Inc.·Product code GXQ·November 22, 2024

Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

FDA Recall
Open, Classified ·Cook Biotech, Inc.·Product code OWV·November 22, 2024

Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.

FDA Recall
Open, Classified ·Cook Biotech, Inc.·Product code KHJ·November 22, 2024

Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4

FDA Recall
Open, Classified ·Daavlin Distributing Company·Product code FTC·December 10, 2025

Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

FDA Recall
Open, Classified ·Synthes USA HQ, Inc.·Product code KTT·October 12, 2012