Pyng Medical Recalls Tourniquets Not Reset to Ready Position
Pyng Medical is recalling MATResponder and MATCombat tourniquets because some were not returned to the Ready position before packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the issue is a procedural deviation (failure to reset the device) rather than a confirmed defect causing injury or a high-risk pathogen, fitting the Moderate criteria for low-risk contamination or voluntary precautionary measures.
Plain-English summary
Pyng Medical Corporation is recalling 6,728 units of MATResponder and MATCombat manual nonpneumatic tourniquets. These devices are used for emergency blood flow occlusion to the limbs.
The recall was initiated because, although each tourniquet was tested for functionality, some units were not returned to the Ready position prior to being placed in their packaging. This deviation from the required testing procedure may affect the device's readiness for immediate use.
The affected products were distributed worldwide, including in the United States and various international markets. Consumers and healthcare providers should stop using these specific lots and contact Pyng Medical for instructions on returning the devices.
The recalled product
- Product
- MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet…
- Manufacturer
- Pyng Medical Corporation
- Affected units
- 6,728
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 (7)
- MATR: lot numbers
- SL115802 (Exp 07/2024)
- SL12136 (Exp 08/2024)
- SL121360 (Exp 12/2024)
- SL114711 (Exp 01/2024) MATC - lot numbers : SL12131 (Exp 07/2024)
- SL121312 (Exp 08/2024)
- SL113171 (Exp 10/2023).
Distribution
Distribution scope not specified by the agency.
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