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Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·August 6, 2024

Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Number: 722234;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·October 2, 2025

Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 S-316 SOFSILK* 0 BLK 12X75CM PCT X24 S-317 SOFSILK* 1 BLK 12X75CM PCT X24 S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 S-606 SOFSILK* 0 BLK 2X150CM PCT X36 S606-12 SOFSILK* 0 BLK 2X150CM PCT X12 S-610 SOFSILK* 5 BLK 2X150CM PCT X12 SOFSILK 2-0 30 BK CV-24 GS453-2 SOFSLK 4-0 24 BK CV-15 DA VS581-2 ***Added 4/1/24*** CS-792 SOFSILK* 0 BLK 100CM GCC90 X36 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S-1735 SOFSILK* 4-0 BLK 30CM C1 DA X12 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 S-1789K SOFSILK* 4-0 BLK 45CM HE3 X12 S-187 SOFSILK* 1 BLK 6X45CM PCT X36 S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 S-2780K SOFSILK* 6-0 BLK 45CM SS-24DA S-282 SOFSILK* 5 BLK 3X60CM PCT X36 S-318 SOFSILK* 2 BLK 12X75CM PCT X24 S-608 SOFSILK* 2 BLK 2X150CM PCT X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 VS872-2 SOFSILK 3-0 30 BK CV-23 VS872-2 SS-1694G SOFSILK 4/0 BLK 45CM P24 X12 SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 SS-5649G SOFSILK* 6-0 BLK 45CM P13 X12 SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 SS-675 SOFSILK* 3-0 BLK 75CM C16 X36 SS-681 SOFSILK* 6-0 BLK 45CM C12 X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 XX-5280 SOFSILK* 0 BLK 150CM PCT X36 -- Ti-Cron Coated Braided Polyester Sutures: 3087-31 TICRON* 4-0 BLU 75CM CV-331DA 3226-31 TICRON* 4-0 BLU 60CM CV330 DA 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863087-31 TICRON* 4-0 BLU 75CM CV33DA 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863147-83 TICRON 2 BLU 5X75CM KV37X12 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-31 TICRON* 4-0 BLU 75CM CV331 88863226-31 TICRON* 4-0 BLU 60CM CV330DA 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863229-31 TICRON* 4-0 BLU 75CM CV307DA 88863271-31 TICRON* 4-0 BLU 90CM CV331DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 -- Monosof Monofilament Nylon Sutures: N-63 MONOSOF* 3-0 BLK 12X45CM PCT X36 SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 -- Steel Monofilament Stainless Steel Sutures 88862224-49 STEEL 7 4X45CM SCC X12

FDA Recall
Open, Classified ·Product code GAP·December 21, 2023

epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU 11413497 epoc NXS Host, Japan 11413498 epoc NXS Host, Canada 11413506 epoc NXS Host, ROW 11413518 epoc NXS Host, China-Korea 11413583

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022

Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component

FDA Recall
Open, Classified ·C-RAD POSITIONING AB Bredgrand 18 Uppsala Sweden·Product code IYE·April 22, 2025

General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C

FDA Recall
Open, Classified ·Cypress Medical Products LLC·Product code FMF·August 6, 2024

Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No

FDA Recall
Open, Classified ·Diagnostica Stago, Inc.·Product code DAP·February 5, 2026

epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished 10736395 epoc Host 2, Chinese, Refurbished 10736433 epoc Host 2, US (MC55X) 11413524 epoc Host 2, ROW (MC55X) 11413528 epoc Host 2, India (MC55X) 11413541 epoc Host 2, China (MC55X) 11413542 epoc Host 2, Japan (MC55X) 11413543 epoc Host 2 (MC55X) - US - Refurbished 11413601 "epoc Host 2 (MC55X) - ROW -Refurbished" 11413602 epoc Host 2 (MC55X) - India - Refurbished 11413603 epoc Host 2 (MC55X) - Japan - Refurbished 11413604

FDA Recall
Open, Classified ·Siemens Healthcare Diagnostics Inc·Product code CHL·December 12, 2022

IQon Spectral CT; Product Code (REF): 728332;

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAK·January 7, 2026

Spectral CT 7500 on Rails; Product Code (REF): 728334;

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAK·January 7, 2026

Brilliance iCT; Product Code (REF): 728306;

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAK·January 7, 2026

Spectral CT; Product Code (REF): 728333;

FDA Recall
Open, Classified ·Philips North America Llc·Product code JAK·January 7, 2026

Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452

FDA Recall
Open, Classified ·Luminex Corporation·Product code OZZ·February 20, 2019

ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

FDA Recall
Open, Classified ·Luminex Corporation·Product code OOI·February 20, 2019

ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295

FDA Recall
Open, Classified ·Luminex Corporation·Product code PGI·February 20, 2019

ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

FDA Recall
Open, Classified ·Luminex Corporation·Product code NJR·February 20, 2019

ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158

FDA Recall
Open, Classified ·Luminex Corporation·Product code OZE·February 20, 2019

ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059

FDA Recall
Open, Classified ·Luminex Corporation·Product code OZN·February 20, 2019

ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469

FDA Recall
Open, Classified ·Luminex Corporation·Product code PGX·February 20, 2019

Product: STA Liatest D-Di; REF: 00515;

FDA Recall
Open, Classified ·Diagnostica Stago, Inc.·Product code DAP·September 12, 2025