JETT Blood Flow Occlusion Devices Recalled for Manufacturing Defect
North American Rescue is recalling 552 JETT devices used to control bleeding in limbs due to a potential manufacturing defect that may compromise device performance during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a risk-of-harm medical device. The manufacturing defect may compromise structural integrity and device performance. No injuries have been reported, placing this within the High severity category for risk-of-harm products without demonstrated harm.
Plain-English summary
North American Rescue LLC is recalling 552 units of the JETT (Junctional Emergency Treatment Tool), reference number 30-0088, a medical device used to control blood flow to the lower limbs. The device is included in multiple trauma care kits and training kits, including TCCC (Tactical Combat Casualty Care) Training kits and the Multi Mission Expeditionary Response Kit (MMERK).
The company initiated the recall due to a potential manufacturing defect that may compromise the structural integrity of the device and its performance during use.
The affected devices have been distributed nationwide across the United States and internationally. U.S. distribution includes South Carolina, Oklahoma, Idaho, Kentucky, Virginia, Nevada, Illinois, Texas, California, Florida, Louisiana, New York, Maine, Pennsylvania, Arkansas, Arizona, Alabama, Delaware, Massachusetts, Mississippi, Hawaii, Washington, Michigan, Georgia, New Jersey, Utah, Maryland, Oregon, and North Carolina. International distribution includes South Korea, Japan, Botswana, Saudi Arabia, and Belgium.
Persons who have received affected JETT devices should contact North American Rescue LLC for information about whether their device is affected and for instructions on replacement or remediation.
The recalled product
- 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
- Manufacturer
- North American Rescue LLC.
- Category
- Medical Device — Trauma Care
- Hazard
- structural-defect
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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