Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 11, 2015
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 devices. The device provides for emergency blood flow occlusion to the limbs
Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Each tourniquet was tested for functionality, but in some cases, t…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Pyng Medical Corporation recalled MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Cat… - a moderate-severity action.
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Cat… was recalled by Pyng Medical Corporation in November 11, 2015. Reason: Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packagin…. Check the official notice for the remedy. Verify recall #Z-0228-2016 with the FDA Devices before acting.
The recall
Pyng Medical Corporation issued this moderate-severity FDA Devices recall-Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packagin….
- Moderate
- severity level
- 7K units
- affected scope
- Class II
- classification
- November 11, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0228-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0228-2016) was formally reported on November 11, 2015, with the manufacturer initiating the action on August 31, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Pyng Medical Corporation is listed as the recalling firm, operating out of Richmond, N/A. Federal records list the affected scope as 6728.
The documented reason for this recall is: Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Each tourniquet was tested for functionality, but in some cases, the tourniquet was not returned to its R… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Distribution and to the countries of : Colombia, France, Canada, Italy, Germany, Finland, United Kingdom, Australia, The Netherlands, Japan, Hungary, Indonesia, Israel, Mexico, Poland an…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6728
Related Recalls
6
3 from same agency
Product description
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 devices. The device provides for emergency blood flow occlusion to the limbs
Reason for recall
Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Each tourniquet was tested for functionality, but in some cases, the tourniquet was not returned to its Ready position prior to packaging.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0228-2016 |
| Date reported | November 11, 2015 |
| Date initiated | August 31, 2015 |
| Recalling firm | Pyng Medical Corporation |
| Firm location | Richmond, N/A |
| Affected scope | 6728 |
| Distribution | Worldwide Distribution - US Distribution and to the countries of : Colombia, France, Canada, Italy, Germany, Finland, United Kingdom, Australia, The Netherlands, Japan, Hungary, Indonesia, Israel, Mexico, Poland and Spain. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0228-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 devices. The device provides for emergency blood flow occlusion to the limbs. Recalled by Pyng Medical Corporation. Units affected: 6728.
Why was this product recalled? ▼
Once tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Each tourniquet was tested for functionality, but in some cases, the tourniquet was not returned to its Ready position prior to packaging.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 11, 2015. Severity: Moderate. Recall number: Z-0228-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Distribution and to the countries of : Colombia, France, Canada, Italy, Germany, Finland, United Kingdom, Australia, The Netherlands, Japan, Hungary, Indonesia, Israel, Mexico, Poland and Spain..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0228-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 11, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.