Data Foundry

Medical device recalls 2024

Kits of Convenience containing 1 of the 2 Item Numbers: 1 — Class II medical device recall Z-3183-2024

Ongoing recall by Safeguard US Operating LLC, reported 2024-09-25, distributed nationwide. Incorrect expiration date.

Recall numberZ-3183-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmSafeguard US Operating LLC, Harrisburg, NC, United States
Recall initiated2024-08-27
Classified2024-09-19
Reported by FDA2024-09-25
DistributedNationwide (US)
Quantity567 units
Reason classeslabeling
Lot numbersPBO0003673, PBO0003913, PBO0004044, PBO0004123, PBO0004172, PBO0004179, PBO0004285, PBO0004291, PBO0004454, PBO0004523, PBO0004817
Model numbers59-300, 59-320

Product

Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set. Convenience kits labeled as follows: Combat Life Saver - Intermediate (Product Number: 83-323-CB) contains 59-300 / 1 Each; Medic Enhancement Resupply (Product Number: 82-504-05) contains 59-300 / 1 Each; Combat Life Saver - Advanced (Product Number: 83-325-CB) contains 59-300 / 1 Each; Cold Weather (Product Number: 82-505) contains 59-300 / 1 Each; HAWK w/ Carrier Set, Multicam, Stocked (Product Number: 83-315-01-MC) contains 59-300 / 1 Each; Mojo Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Combat Life Saver - Intermediate - Multicam (Product Number: 83-323-MC); Mojo Combat Life Saver - Advanced - Multicam (Product Number: 83-325-MC); DIRECT ACTION BAG, FOLIAGE GREEN, ADVANCED, STOCKED (Product Number: 84-497-FG).

Reason for recall

Incorrect expiration date.

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-3183-2024. 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.