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BiomarC EX Fiducial Marker System, Catalog Number 040165 (Carbon Medical Technologies, Inc.) – this recall has been initiated due to... (2024)

This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.

FDAJul 26, 2024Nationwide• Carbon Medical Technologies, Inc.

Atellica IM CA 19-9 (Siemens) – Test Result Bias (2024)

Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.

Moderate

FDAJul 26, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

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BiomarC EX Fiducial Marker System, Catalog Number 040165 (Carbon Medical Technologies, Inc.) – this recall has been initiated due to... (2024)

Atellica IM CA 19-9 (Siemens) – Test Result Bias (2024)

Arrow Arterial Kits and Trays as follows: (1) Arrow Arte... (ARROW INTERNATIONAL Inc.) – reports have been received regarding ... (2024)

CustomEyes Procedure Packs (Beaver Visitec) – Syringe Recall (2024)

Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/... (Intrinsic Therapeutics, Inc.) – at least two units have been found to... (2024)

NEUROSIGN Disposable Stimulating Dissector, REF 5888-00 (Technomed Europe Amerikalaan 71 Maastricht-Airport Netherlands) – product has have presence of brown di... (2024)

Vivo 45 LS, pressure and volume ventilator capable of del... (Breas Medical, Inc.) – there is a potential for short term (... (2024)

CARDIOVIT AT-180. Model Number: 0A.110000; Catalog number... (Schiller, Ag Altgasse 68 Baar Switzerland) – potential for high-frequency signal a... (2024)

McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 10... (Cypress Medical Products LLC) – affected syringes lack fda clearance (2024)

FreeStyle Libre 3 Sensors, REF: 72081-01, component of th... (Abbott Diabetes Care, Inc.) – laceration hazard (2024)

(a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 1... (Cardinal Health 200, LLC) – the firm received reports of breakage... (2024)

Stryker TMJ Unilateral Implant, REF: GHG010, consisting ... (TMJ Solutions Inc) – patient-fitted temporomandibular (tmj... (2024)

regard Clinical Packaging Solutions, HT00376I - SPECIAL P... (ROi CPS LLC) – medical convenience kits were distrib... (2024)

Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope ... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

VariSoft Infusion Set, Single Use. (Unomedical A/S Osted Aholmvej 1) – specific varisofttm infusion sets wer... (2024)

Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MI... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

GE Healthcare Centricity Universal Viewer Zero Footprint ... – fire hazard (2024)

Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)

Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope ... (Karl Storz Endoscopy) – various medical device product ifus c... (2024)