33 results
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22ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code N/A·July 17, 2019
Kit BD Max ExK DNA 2 EU LUO; Catalog # 442820
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code N/A·July 17, 2019
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
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.
FDA Recall
Terminated
·SEPPIM SAS ZONE INDUSTRIELLE SEES France·Product code CJY·September 4, 2013
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
FDA Recall
Terminated
·Carbon Medical Technologies, Inc.·Product code NEU·December 16, 2022
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
Medtronic One Source Pack Magellan, Catalog Number: COS310. Kits are packaging convenience kits containing previously released sterile-pack products and accessories. Medtronic Ideal MAXPAC Total System
FDA Recall
Terminated
·Medtronic Cardiovascular Revascularization & Surgical Therap·Product code OEU·March 23, 2009
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
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, Non-pyrogenic, Rx only; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4313800 Rev. 1 01/11 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code NEU·January 23, 2013
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
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
FDA Recall
Terminated
·Devicor Medical Products Inc·Product code NEU·March 30, 2022
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic, Rx only, Single Use; Bard Peripheral Vascular, Inc., 1625 West 3rd Street, Tempe, AZ 85281 USA. PK4320100 Rev. 0 03/10 The UltraClip Dual Trigger breast tissue marker is a sterile, single use device comprised of a disposable introducer, and a metal implantable tissue marker with polyvinyl alcohol (PVA).
FDA Recall
Terminated
·Bard Peripheral Vascular Inc·Product code NEU·January 23, 2013
BioZorb Marker. Radiographic soft tissue marker.
FDA Recall
Open, Classified
·Hologic, Inc·Product code NEU·October 10, 2024
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
FDA Recall
Terminated
·Somatex Medical Technologies GmbH Rheinstr. 7 d Teltow Germany·Product code NEU·May 22, 2017
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
Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box with lid. This box is then placed into a solid white box. Item is shipped and sold non-sterile. It is intended to be used to radiographically (with X-Ray) mark the site of the "gastropexy" performed during gastric bypass surgery, thereby making it accessible for future diagnostic, therapeutic and feeding purposes.
FDA Recall
Terminated
·Kapp Surgical Instrument Inc·Product code NEU·May 24, 2011