FDA Device recall Z-2637-2025
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550
- FDA Device
- Class II
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class II recall of JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550 by North American Rescue, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2637-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-01 |
| Published | 2025-10-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | North American Rescue |
| Distribution | US |
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
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.
Identifiers
| code_info | JETT: REF: 30-0088 UDIs: (01)00842209100002(11)240426(10)0212241, (01)00842209100002(11)240515(10)817221, (01)00842209…JETT: REF: 30-0088 UDIs: (01)00842209100002(11)240426(10)0212241, (01)00842209100002(11)240515(10)817221, (01)00842209100002(11)240530(10)817222, (01)00842209100002(11)240618(10)817222, (01)00842209100002(11)240701(10)817222, (01)00842209100002(11)240712(10)1213231. REF: 30-0088: Lots: 021224-1, 81722-1, 81722-2, 121323-1. Kits: REF/UDI-DI/Lot: 85-0550/00842209110711/85-0550091824, 85-0550090424, 85-0550030725, 85-0550052925, 85-0550052325, 85-0550082324, 85-0550080624, 85-0550062624, 85-0550052124, 85-0550111424, 85-0550102924; 85-0519/00842209110742/85-0519090324, 85-0519081924; 85-2420/00842209113910/85-2420041725, 85-2420042125, 85-2420100324; 85-0740/00842209110599/85-0740042925, 85-0740050625, 85-0740052925, 85-0740081224, 85-0740082924, 85-0740011325, 85-0740122324, 85-0740121724, 85-0740112024, 85-0740110424, 85-0740102524; 85-1900/00842209110810/85-1900082124, 85-1900031125 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2637-2025%22
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