Data Foundry

Medical device recalls 2026

AIDBAGs are first aid kits of convenience composed of individually… — Class I medical device recall Z-1947-2026

Ongoing recall by North American Rescue LLC., reported 2026-05-06, distributed in CA, WA. Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled

Recall numberZ-1947-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmNorth American Rescue LLC., Greer, SC, United States
Recall initiated2026-03-27
Classified2026-04-29
Reported by FDA2026-05-06
DistributedCA, WA
Quantity21
Reason classessoftware
UPC / GTIN / UDI-DI00842209132089, 00842209133536, 20612479197217
Model numbers98317

Product

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).

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1947-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.