JUNCTIONAL EMERGENCY TREATMENT TOOL — Class II medical device recall Z-2637-2025
Ongoing recall by North American Rescue LLC., reported 2025-10-08, distributed nationwide. Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturi
| Recall number | Z-2637-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | North American Rescue LLC., Greer, SC, United States |
| Recall initiated | 2025-07-01 |
| Classified | 2025-09-26 |
| Reported by FDA | 2025-10-08 |
| Distributed | Nationwide (US) |
| Quantity | 552 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00842209100002, 00842209110599, 00842209110711, 00842209110742, 00842209110810, 00842209113910 |
| Lot numbers | 021224-1, 121323-1, 81722-1, 81722-2, 85-0519081924, 85-0550030725, 85-0550052124, 85-0550052325, 85-0550052925, 85-0550062624, 85-0550080624, 85-0550082324, 85-0550090424, 85-0550102924, 85-0550111424, 85-0740011325, 85-0740050625, 85-0740052925, 85-0740081224, 85-0740082924, 85-0740102524, 85-0740110424, 85-0740112024, 85-0740121724, 85-0740122324, 85-1900031125, 85-2420042125, 85-2420100324 |
| Model numbers | 021224-1, 121323-1, 30-0088, 81722-1, 81722-2, 85-0519, 85-0550, 85-0740, 85-1900, 85-2420 |
Product
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK COMBO, REF: 85-0740, KIT, TCCC/TECC MODULE ONE SKILLS REFILL, REF: 85-1900
Reason for recall
Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.
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-2637-2025. 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.