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Channel: Medical Device Recalls since April 03, 2025
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Siemens Healthcare Diagnostics - IMMULITE /IMMULITE 1000 Systems COR - Class...

IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement...

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Straumann USA, LLC - Straumann Bone Level Tapered Implant - Class 2 Recall

Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to...

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Coloplast Manufacturing US, LLC - Biatain Super NonAdhesive - Class 3 Recall

Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low...

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Cooper Vision Caribbean Corp. - ProClear Toric Soft Hydrophilic Contact...

ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint (VAT Blue...

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Siemens Healthcare Diagnostics, Inc - Siemens ADVIA Centaur Calibrator C -...

ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 672182005 (US Reference 6 pack)

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Siemens Healthcare Diagnostics, Inc - SiemensADVIA Centaur Calbarator C -...

ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 06567787 (6 pack)

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Siemens Healthcare Diagnostics, Inc - SiemensADVIA Centaur Calibrator C -...

ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system only. (In-Vitro Diagnostic) Catalog Number: 03439230 (2 pack)

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Animas Corporation - Animas Vibe Insulin Infusion Pump and System - Class 2...

Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.

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Cook Medical Incorporated - Spirotome - Class 2 Recall

Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that...

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Maquet Cardiovascular, LLC - Acrobat V Vacuum OffPump System - Class 2 Recall

Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump System OM-9000S Axius Xpose 3 Access Device XP-3000 XPOSE 4 Access Device XP-4000 Acrobat V Vacuum Off-Pump System Each Acrobat V...

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Abbott Laboratories - Abbott Laboratories HbA1c Calibrators - Class 2 Recall

HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to...

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Animas Corporation - Animas Vibe Insulin Infusion Pump - Class 2 Recall

Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature.

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Siemens Healthcare Diagnostics, Inc. - Dimension Vista HbA1c - Class 2 Recall

Dimension Vista¿ HbA1c

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Bausch & Lomb Inc- Greenville Solutions Plant - Equate - Class 2 Recall

Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc., Bentonville, AR 72716

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Hospira Inc. - GemStar Medical Power Supply - Class 1 Recall

The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120...

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Hospira Inc. - GemStar Medical Power Supply - Class 1 Recall

The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120...

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Biosense Webster, Inc. - THERMOCOOL SMARTTOUCH NAVIGATION Catheter - Class 2...

ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.

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Trumpf Medical Systems, Inc. - TITAN - Class 2 Recall

TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the...

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C P Medical, Inc. - Monoswift - Class 2 Recall

Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It...

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Merge Healthcare, Inc. - Merge Hemo Programmable diagnostic computer - Class...

Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial...

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