125 results
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25ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery.
FDA Recall
Open, Classified
·Elucent Medical Inc·Product code NEU·November 18, 2024
Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH
FDA Recall
Open, Classified
·Product code NLH·December 22, 2025
Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.
FDA Recall
Open, Classified
·Medline Industries Inc·Product code LRO·April 30, 2021
Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81105RH 81172RH; Abbott Inquiry Steerable Diagnostic Catheter 20 Elec. 2-10-2mm 81202RH; Abbott Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81483RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 2-5-2mm 81102RH 81104RH 81174RH 81531RH 81532RH; Inquiry Steerable Diagnostic Catheter 10 Elec. 5mm 81107RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 2-5-2mm 81402RH 81404RH 81405RH 81474RH; Inquiry Steerable Diagnostic Catheter 4 Elec. 5mm 81473RH
FDA Recall
Open, Classified
·Product code NLH·December 22, 2025
Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH;
FDA Recall
Open, Classified
·Product code NLH·December 22, 2025
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
FDA Recall
Open, Classified
·Monarch Medical Technologies·Product code NDC·May 3, 2019
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad Surgical Lights)
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FTD·June 4, 2024
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code KQM·June 4, 2024
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FTD·June 4, 2024
2008T HD SYS. W/O CDX BLUESTAR
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023
2008T Hemodialysis System without CDX
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023
2008T HD SYS. CDX BLUESTAR
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023
2008T Hemodialysis System w/Bibag
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023
2008T Hemodialysis SYS, with CDX
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023
2008T GEN 2 Bibag without CDX
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023
2008T HD SYS. CDX W/BIBAG BLUESTAR
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
FDA Recall
Open, Classified
·Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
850 W. Rio Salado Prkwy.
Tempe AZ 85281-2438·Product code MCW·February 5, 2025
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·September 6, 2023
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·June 3, 2024
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
FDA Recall
Open, Classified
·Fresenius Medical Care Holdings, Inc.·Product code KDI·June 3, 2024