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Channel: Medical Device Recalls since June 26, 2025
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Zimmer, Inc. - Zimmer Trabecular Metal - Class 2 Recall

00434811113, REF I4348-111-13 Zimmer¿ Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem LengthTrabecular Metal" Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx...

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Hologic, Inc - NovaSure Radiofrequency Control Units - Class 2 Recall

NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Controlled Endometrial...

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Fresenius Medical Care Holdings, Inc. - FreseniusOptiflux F18Nre Flux...

Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.

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Fresenius Medical Care Holdings, Inc. - Fresenius Optiflux B200 Flux...

Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.

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Fresenius Medical Care Holdings, Inc. - Fresenius Optiflux F160NRe High Flux...

Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment.

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Fresenius Medical Care Holdings, Inc. - Fresenius Optiflux F200A High Flux...

Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment.

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Fresenius Medical Care Holdings, Inc. - Fresenius Optiflux F200NR High Flux...

Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment.

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Fresenius Medical Care Holdings, Inc. - Fresenius Optiflux F200NRe High Flux...

Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.

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Fresenius Medical Care Holdings, Inc. - Fresenius Optiflux F180NR High Flux...

Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.

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Fresenius Medical Care Holdings, Inc. - Fresenius Optiflux F180NRe High Flux...

Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment.

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Fresenius Medical Care Holdings, Inc. - Fresenius Optiflux F160NR High Flux...

Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment.

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Philips Medical Systems, Inc. - Philips HeartStart MRx Monitor/Defibrillator...

Philips HeartStart MRx Monitor/Defibrillator used Model numbers: M3535A, M3536A, M3536J, M3536M, M3536MC

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Winco Mfg., LLC - CONVALESCENT RECLINER - Class 2 Recall

CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position...

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Winco Mfg., LLC - DROPARM CONVALESCENT RECLINER - Class 2 Recall

DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners...

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Winco Mfg., LLC - PREMIER CARE RECLINER 5570 - Class 2 Recall

PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi...

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Winco Mfg., LLC - XL CONVALESCENT RECLINER - Class 2 Recall

XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame...

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Dako North America Inc. - Dako HER2 CISH pharmDx(tm) kit - Class 2 Recall

Product Name: HER2 CISH pharmDx" Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is intended for dual-color chromogenic visualization of...

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Philips Medical Systems, Inc. - Philips HeartStart MRx Monitor/Defribillator...

Philips HeartStart MRx Monitor/Defibrillator; Models: M3535A, M3536A, M3536J, M3536M, M3536M5, and M3536MC. Used for the termination of ventricular tachycardia and ventricular fibrillation.

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Philips Medical Systems, Inc. - Philips Healthcare - Class 2 Recall

HeartStart MRx Defibrillator/Monitor M3538A Lithium Ion Batteries Revision J The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for...

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Invivo Corporation - Invivo Corporation Expression IP5 Information Portal -...

Invivo Corporation Expression IP5 Information Portal Product Usage: The Expression Information Portal (Model IP5) a display and device controller for Philips MRI patient monitoring systems, is intended...

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