1,185 results · 27ms · Sources: EU EUDAMED, US FDA

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Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F; 2. RescuMed Infant Resuscitator REF #s: BVMB710 & BVMB710-F; 3. RescuMed Pediatric Resuscitator REF #s: BVMB812, BVMB812-F, BVMB810, BVMB810-F, BVMB810S-F.

FDA Recall
Open, Classified ·SunMed Holdings, LLC·Product code BTM·October 11, 2023

#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED

FDA Recall
Open, Classified ·Baxter Healthcare Corporation·Product code CCW·May 17, 2022

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter

FDA Recall
Open, Classified ·Abbott·Product code OAE·September 10, 2025

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

Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045/B, 28MC21130SN/CNB, 28MC21130ST/B, 28MC2115045/B, 28MC2115045/C, 28MC21150SN/B, 28MC21150ST/B, 28MC2411045/D, 28MC24110SN/D, 28MC24110ST/D, 28MC2413045/D, 28MC24130SN/F, 28MC24130ST/D, 28MC24130ST-W/A, 28MC2415045/D, 28MC24150ST/D, 28MC24150ST/F, 28MC28110ST/D, 28MC2813045/D, 28MC28130SN/D, 28MC28130SN/F, 28MC28130ST/D, 28MC28150SN/D, 28MC28150SN/F, 29MC2911045/D, 29MC29130SN/F, 29MC29130ST/D, 29MC29150ST/CNB, 29MC29150ST/D, CE 2797, STERILEEO, Rx ONLY

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code KRA·November 6, 2023

Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

FDA Recall
Open, Classified ·Merit Medical Systems, Inc.·Product code DRE·August 12, 2024

RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component

FDA Recall
Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

FDA Recall
Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020

FDA Recall
Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISH·May 12, 2023

Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

FDA Recall
Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQK·August 20, 2024

RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

FDA Recall
Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

FDA Recall
Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024

Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002

FDA Recall
Open, Classified ·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·December 26, 2023

Digital Angiography System Trinias:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST safire:UD150G-40 / D150GC-40; Digital Angiography System BRANSIST alexa:UD150G-40 / D150GC-40; Digital Radiography System RADspeed Pro: UD150B-40 / UD150V-40 / UD150L-40 / UD150L-40E/D150BC-40 / D150VC-40 / D150LC-40 / D150LC-40E/D150BC-41 / D150VC-41 / D150LC-41; Digital Radiography System RADspeed safire: UD150B-40 / D150BC-40; Radiography System RADspeed fit: N/A (Integrated in the system); X-RAY R/F SYSTEM SONIALVISION safire17:UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION safire Plus: UD150B-40 / D150BC-4;0 X-RAY R/F SYSTEM SONIALVISION safire: UD150B-40 / D150BC-40; X-RAY R/F SYSTEM SONIALVISION VERSA: UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM FLUOROspeed 300:UD150B-40 / UD150V-40 / UD150L-40/D150BC-40 / D150VC-40 / D150LC-40; X-RAY R/F SYSTEM SONIALVISION G4:D150BC-40S; X-RAY R/F SYSTEM FLUOROspeed X1:D150BC-40S

FDA Recall
Open, Classified ·Shimadzu Medical Systems·Product code OWB·April 20, 2026

RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numbers: a) 504550 b) 504555 c) 504560 d) 504565 e) 504570 f) 504575 g) 504580 f) 504585 g) 504590

FDA Recall
Open, Classified ·Teleflex Medical Europe Ltd Ida Business Park Athlone Ireland·Product code BTR·July 16, 2021

Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product Description: SEALING UNIT F/10/12MM TROCARS W.REDUCER Component: N/A

FDA Recall
Open, Classified ·Aesculap Inc·Product code GCJ·September 24, 2025

DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. CATALOG #(s): 8624181 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8624199 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F 8621617 X-RAY SYSTEM CONSOLE PDU 3P 380-480 C/F 8622359 X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F Note: PDU is a standalone Power Distribution Unit (PDU), plugged into the hospital outlet, which supplies Alternate Current (AC) to the Overhead Tube Crane (OTC).

FDA Recall
Open, Classified ·Carestream Health, Inc.·Product code KPR·January 30, 2023

Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, VN3100MBP-3M, VN3100MB, VN3100MB-D1, VN3100MB-M00-0, VN3100MB-M1, VN3100OBP, VN3100MB-B, VN3100MB-I, VN3100MBP-000, VN3100MBP-2, VN3100MB-PW2, VN3100MBP, VN3100MBP-D1, VN3100MBPW-D2, VN3100MBP-F, VN3100MXK-2, VN3100MX-F, VN3100MC-2, VN3100MC, VN3100MC-B, VN3100MC-D1, VN3100MC-2U, VN3106MC-M1-2V, VN3104MCFB- M01, VN3106MC-D2V, VN3106MC-M1V, VN3100MCP-2, VN3100MCP, VN3106MCPF- M1V, VN3100MBF; 3. V-Care Pediatric Resuscitator REF #s: VN2100MB, VN2102MB, VN2102MBF, VN2102OBP, VN2100MBF, VN2100MBP, VN2100MB-PW, VN2102MX, VN2102MX-F, VN2100MX-M123, VN2100MC, VN2102MC, VN2102MC-B, VN2102MCP, VN2100MCP; 4. V-Care Small Adult Resuscitator REF #s: VN5000MB, VN5002MB, VN5100MB-F, VN5000MBPF, VN5000MBPF-I, VN5000MX, VN5100MX-F, VN5000MX-N, VN5000MXP, VN5000MXP-K, VN5000MC, VN5102MC, VN5100MCP, VN5000MC-N.

FDA Recall
Open, Classified ·SunMed Holdings, LLC·Product code BTM·October 11, 2023

CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAA·September 21, 2023

ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAA·September 21, 2023