15 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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Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
FDA Recall
Open, Classified
·Wilson-Cook Medical Inc.·Product code QAU·October 31, 2024
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
FDA Recall
Open, Classified
·Wilson-Cook Medical Inc.·Product code QAU·May 22, 2023
Color contact lenses labeled under the following brands: Diamond, Fierce, Ambition, Circle Collection, Lunatic, Fright, Desire and See Clear.
FDA Recall
Open, Classified
·The See Clear Company·Product code LPL·January 6, 2017
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker 3cm x 4cm 7) F0303 BioZorb Marker 3cm x 3cm 8) F0203 BioZorb Marker 2cm x 3cm 9) F0202 BioZorb Marker 2cm x 2cm
FDA Recall
Open, Classified
·Hologic, Inc·Product code NEU·March 13, 2024
Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
FDA Recall
Open, Classified
·Cepheid·Product code PEU·November 5, 2025
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue.
FDA Recall
Open, Classified
·Stryker Corporation·Product code NEU·January 21, 2026
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.
FDA Recall
Open, Classified
·Hologic, Inc·Product code NEU·August 9, 2022
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
FDA Recall
Open, Classified
·Devicor Medical Products Inc·Product code NEU·April 24, 2026
BioZorb Marker. Radiographic soft tissue marker.
FDA Recall
Open, Classified
·Hologic, Inc·Product code NEU·October 10, 2024
Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
FDA Recall
Open, Classified
·ENDOMAGNETICS LTD St. Johns Innovation Park Cowley Road Cambridge United Kingdom·Product code NEU·October 1, 2025
Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a 17ga Needle Delivery System. The Endomag Magseed Pro Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
FDA Recall
Open, Classified
·ENDOMAGNETICS LTD St. Johns Innovation Park Cowley Road Cambridge United Kingdom·Product code NEU·October 1, 2025
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
Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue. The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.515 mm and 14.525.5 mm. Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic). The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes. The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed. Component: NO
FDA Recall
Open, Classified
·LEASEIR TECHNOLOGIES SLU Calle Marconi G 246 Gijon Spain·Product code GEX·December 15, 2025
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
FDA Recall
Open, Classified
·Visgeneer, Inc.
No. 335 Zhong Hua Rd., Sec. 6
Xiangshan Dist.
Hsinchu City Taiwan·Product code PTC·October 4, 2023
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
FDA Recall
Open, Classified
·Visgeneer, Inc.
No. 335 Zhong Hua Rd., Sec. 6
Xiangshan Dist.
Hsinchu City Taiwan·Product code PTC·October 4, 2023