1,054 results · 21ms · Sources: EU EUDAMED, US FDA

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CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and prior. These CellMek devices include Cassette E.

FDA Recall
Open, Classified ·Beckman Coulter, Inc.·Product code PER·September 8, 2025

BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base), REF: 663128, 662588, used with software V 1.4.1. Intended use: to prepare human specimens to be analyzed.

FDA Recall
Open, Classified ·Becton, Dickinson and Company, BD Bio Sciences·Product code PER·August 12, 2024

Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting, diluting, and specimen processing workstations for flow cytometric analysis.

FDA Recall
Open, Classified ·Sysmex America, Inc.·Product code PER·January 6, 2025

CellMek SPS Sample Preparation System, REF: C44603, with software

FDA Recall
Open, Classified ·Beckman Coulter, Inc.·Product code PER·December 23, 2025

Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case; e. Glove 8.5 Pack, 25 Pairs, 10 packs per case; f. Glove 9.0 Pack, 25 Pairs, 10 packs per case;

FDA Recall
Open, Classified ·Stradis Healthcare·Product code PXC·December 15, 2022

Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CAE·March 9, 2022

Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code HFX·May 23, 2023

10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

FDA Recall
Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FMF·August 8, 2023

3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case

FDA Recall
Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code FMF·August 8, 2023

VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)

FDA Recall
Open, Classified ·Ortho-Clinical Diagnostics, INc.·Product code CHI·September 12, 2023

Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.

FDA Recall
Open, Classified ·Stradis Healthcare·Product code LRS·December 15, 2022

Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.

FDA Recall
Open, Classified ·Stradis Healthcare·Product code LRS·December 15, 2022

3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary carton, and 4 primary cartons per shipper box.

FDA Recall
Open, Classified ·3M Company Health Care Business 3m Center·Product code KGX·February 20, 2024

IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX Station Pharmacy Compounding System.

FDA Recall
Open, Classified ·Omnicell, Inc.·Product code LHI·February 20, 2025

CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.

FDA Recall
Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code NAC·January 23, 2024

Blue OR Towels, X-Ray Detectable, Sterile, 2 Towels per/pk; 48pk/Cs and 4 Towels per/pk; (20pk/Cs). Intended for packing and absorption externally or within patient wounds in various procedures or surgical cases.

FDA Recall
Open, Classified ·Medical Action Industries Inc·Product code GDY·April 19, 2017

Cardioblate" Gemini"-s Irrigated RF Surgical Ablation System; The device is placed in a plastic tray with a snap on plastic lid, the tray is placed in protective wrap, then into a sterile pouch, 1 device per carton, 1 carton per box.

FDA Recall
Open, Classified ·Medtronic Perfusion Systems·Product code OCL·April 20, 2022

Custodiol HTK Solution, 500ml bottle. 10 per carton.

FDA Recall
Open, Classified ·Dr Franz Koehler Chemie Gmbh Werner-Von-Siemens-Str. 14-28 Bensheim Germany·Product code KDL·January 9, 2024

remel BactiDrop Acridine Orange, REF 21502, 50 per package.

FDA Recall
Open, Classified ·Remel, Inc·Product code JFO·September 20, 2024

Imager II 5F Angiographic Catheters, 5 units per package.

FDA Recall
Open, Classified ·Boston Scientific Corporation·Product code DQO·February 11, 2020