Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 5, 2018
Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 35…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Smiths Medical Asd Inc. recalled Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device … - a moderate-severity action.
Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device … was recalled by Smiths Medical Asd Inc. in December 5, 2018. Reason: Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in…. Check the official notice for the remedy. Verify recall #Z-0512-2019 with the FDA Devices before acting.
The recall
Smiths Medical Asd Inc. issued this moderate-severity FDA Devices recall-Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in….
- Moderate
- severity level
- 2K units
- affected scope
- Class II
- classification
- December 5, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0512-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0512-2019) was formally reported on December 5, 2018, with the manufacturer initiating the action on November 19, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Smiths Medical Asd Inc. is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 2,425 devices.
The documented reason for this recall is: Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924 Distribution data in the federal record shows the product reached: The potentially affected products were shipped to customers in the US, Canada, and Mexico.. 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 - 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 - 40,422 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
2,425 devices
Related Recalls
6
0 from same agency
Product description
Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.
Reason for recall
Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0512-2019 |
| Date reported | December 5, 2018 |
| Date initiated | November 19, 2018 |
| Recalling firm | Smiths Medical Asd Inc. |
| Firm location | Minneapolis, MN |
| Affected scope | 2,425 devices |
| Distribution | The potentially affected products were shipped to customers in the US, Canada, and Mexico. |
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-0512-2019) 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? ▼
Medex High Pressure Stopcock used to control the direction of IV fluid flow. This device is intended for single use only and is provided sterile and fluid path non-pyrogenic unless package is damaged or opened.. Recalled by Smiths Medical Asd Inc.. Units affected: 2,425 devices.
Why was this product recalled? ▼
Certain lots of Medex" High Pressure Stopcocks were manufactured with an inner body defect that may result in a leak. Model Number - Lot Number MX4301L - 3538569 MX4331L - 3562377 & 3546826 MX4331R - 3546924
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 5, 2018. Severity: Moderate. Recall number: Z-0512-2019.
Where was the recalled product distributed? ▼
Distribution: The potentially affected products were shipped to customers in the US, Canada, and Mexico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0512-2019) 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 December 5, 2018. 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.