FDA Device Recalls

Class IOngoing

AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).

North American Rescue LLC.

Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.

March 27, 2026 · DeviceView details →

Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A

Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments

Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments

Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO

Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15

Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300

Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27

Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23

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

Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20

Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25

Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.

Heraeus, PALAMIX uno. Material Number: 66057893.

DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25

DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23