Medex LOGICAL CATH LAB KIT, List Number M20754

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An in…

Recall #: Z-0739-2024
Affected scope: 31,685 total
Initiated: November 10, 2023

Compiled from official public sources by the publisher. · Updated September 2026

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Smiths Medical Asd Inc recalled Medex LOGICAL CATH LAB KIT, List Number M20754 - a moderate-severity action.

Medex LOGICAL CATH LAB KIT, List Number M20754 was recalled by Smiths Medical Asd Inc in January 24, 2024. Reason: There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter o…. Check the official notice for the remedy. Verify recall #Z-0739-2024 with the FDA Devices before acting.

The recall

Smiths Medical Asd Inc issued this moderate-severity FDA Devices recall-There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter o….

Moderate
severity level: Class II
classification: January 24, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0739-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

Medex LOGICAL CATH LAB KIT, List Number M20754

Reason for recall

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Ongoing
Recall number	Z-0739-2024
Date reported	January 24, 2024
Date initiated	November 10, 2023
Recalling firm	Smiths Medical Asd Inc
Firm location	Dublin, OH
Affected scope	31,685 total
Distribution	Worldwide distribution - US Nationwide and the countries of Canada, UAE.

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-0739-2024) 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 LOGICAL CATH LAB KIT, List Number M20754. Recalled by Smiths Medical Asd Inc. Units affected: 31,685 total.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on January 24, 2024. Severity: Moderate. Recall number: Z-0739-2024.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE..

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.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported January 24, 2024. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026