292 results · 12ms · Sources: EU EUDAMED, US FDA

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Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170

FDA Recall
Open, Classified ·Alere San Diego, Inc.·Product code CGA·March 1, 2024

Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310

FDA Recall
Open, Classified ·PFM MEDICAL INC.·Product code DXE·April 21, 2026

Akkermansia Test

FDA Recall
Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code PPM·November 3, 2025

Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.

FDA Recall
Open, Classified ·Luminex Corporation·Product code PAM·November 7, 2023

NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100

FDA Recall
Open, Classified ·NeuMoDx Molecular Inc·Product code PPM·May 24, 2023

Access Substrate, REF 81906, For use with the Access Immunoassay Systems

FDA Recall
Open, Classified ·Beckman Coulter, Inc.·Product code PPM·February 7, 2024

VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack

FDA Recall
Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code PPM·November 22, 2021

NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

FDA Recall
Open, Classified ·bioMerieux, Inc.·Product code PPM·July 20, 2022

intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20

FDA Recall
Open, Classified ·Biocare Medical, LLC·Product code PPM·September 25, 2024

Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis

FDA Recall
Open, Classified ·Immuno-Mycologics, Inc·Product code PPM·March 26, 2026

ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.

FDA Recall
Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code PPM·April 24, 2025

1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Specimen Processor for Microbiology) System

FDA Recall
Open, Classified ·Copan Italia Via Francesco Perotti 10·Product code PPM·October 29, 2025

Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000

FDA Recall
Open, Classified ·Stryker Medical Division of Stryker Corporation·Product code FZM·May 12, 2021

VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.

FDA Recall
Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code PPM·May 21, 2024

Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512

FDA Recall
Open, Classified ·Agilent Technologies, Inc.·Product code PPM·May 20, 2022

Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test

FDA Recall
Open, Classified ·Luminex Corporation·Product code PAM·June 20, 2024

STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.

FDA Recall
Open, Classified ·Diagnostica Stago, Inc.·Product code PPM·May 21, 2025

1ml of DTT in liquid phase, in PET tube with capture cap, in bulk

FDA Recall
Open, Classified ·Copan Italia Via Francesco Perotti 10·Product code PPM·October 29, 2025

Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004

FDA Recall
Open, Classified ·Princeton Biomeditech Corp·Product code JHI·August 23, 2024

Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

FDA Recall
Open, Classified ·Maquet Cardiopulmonary Gmbh Kehler Str. 31 Rastatt Germany·Product code DTQ·January 9, 2026