Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 19, 2023
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Product that was built for design verification testing was inadvertently distributed to customers.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Merit Medical Systems, Inc. recalled Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A - a moderate-severity action.
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A was recalled by Merit Medical Systems, Inc. in April 19, 2023. Reason: Product that was built for design verification testing was inadvertently distributed to customers.. Check the official notice for the remedy. Verify recall #Z-1352-2023 with the FDA Devices before acting.
The recall
Merit Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Product that was built for design verification testing was inadvertently distributed to customers..
- Moderate
- severity level
- 17 units
- affected scope
- Class II
- classification
- April 19, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1352-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1352-2023) was formally reported on April 19, 2023, with the manufacturer initiating the action on February 15, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Merit Medical Systems, Inc. is listed as the recalling firm, operating out of South Jordan, UT. Federal records list the affected scope as 17 devices.
The documented reason for this recall is: Product that was built for design verification testing was inadvertently distributed to customers. Distribution data in the federal record shows the product reached: U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A. 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
17 devices
Related Recalls
6
3 from same agency
Product description
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Reason for recall
Product that was built for design verification testing was inadvertently distributed to customers.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1352-2023 |
| Date reported | April 19, 2023 |
| Date initiated | February 15, 2023 |
| Recalling firm | Merit Medical Systems, Inc. |
| Firm location | South Jordan, UT |
| Affected scope | 17 devices |
| Distribution | U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A |
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-1352-2023) 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? ▼
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A. Recalled by Merit Medical Systems, Inc.. Units affected: 17 devices.
Why was this product recalled? ▼
Product that was built for design verification testing was inadvertently distributed to customers.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2023. Severity: Moderate. Recall number: Z-1352-2023.
Where was the recalled product distributed? ▼
Distribution: U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1352-2023) 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 April 19, 2023. 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.