Home / Recalls / North American Rescue LLC. / Z-2637-2025

Z-2637-2025 Class II Ongoing

Recalled by North American Rescue LLC. — Greer, SC

FDA device recall Z-2637-2025 was initiated by North American Rescue LLC. on July 1, 2025 and is designated Class II. 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 performanc… The recall status is ongoing. Affected quantity: 552.

Recall Details

Product Type
Devices
Report Date
October 8, 2025
Initiation Date
July 1, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
552

Product Description

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.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of SC, OK, ID, KY, VA, NV, IL, TX, CA, FL, LA, NY, LA, ME, PA, AR, AZ, AL, DE, MA, MS, HI, WA, MI, GA, NJ, UT, MD, OR, NC, NC, AL and the countries of KOR, JPN, BWA, SAU, BEL.

Code Information

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

Other recalls by North American Rescue LLC.

  • Z-1947-2026 Class I — AIDBAGs are first aid kits of convenience composed of individually labeled devic (March 27, 2026)
  • Z-2520-2021 Class II — 10 ga ARS Decompression Needle, Part Number ZZ-0298 (August 27, 2021)
  • Z-3018-2020 Class II — 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in (August 21, 2020)
  • D-0180-2017 Class II — Amphibious Trauma Kit - Product Code 85-0639, North American Rescue (September 27, 2016)
  • D-0178-2017 Class II — Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 8 (September 27, 2016)
  • D-0183-2017 Class II — USCG Boat Response Kit - Product Code 80-0353, North American Rescue (September 27, 2016)
  • D-0181-2017 Class II — Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue (September 27, 2016)
  • D-0177-2017 Class II — Range Trauma Kit - Product Code 85-1274, North American Rescue (September 27, 2016)
  • D-0175-2017 Class II — Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue (September 27, 2016)
  • D-0182-2017 Class II — Aid Backpack Kit - Product Code 85-0917, North American Rescue (September 27, 2016)

FDA data resources