MEDLINE OPEN HEART PACK, REF DYNJ66216C

Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, produc…

Recall #: Z-0121-2025
Affected scope: 123 kits
Initiated: August 28, 2024

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

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Medline Industries, LP - Northfield recalled MEDLINE OPEN HEART PACK, REF DYNJ66216C - a moderate-severity action.

MEDLINE OPEN HEART PACK, REF DYNJ66216C was recalled by Medline Industries, LP - Northfield in October 23, 2024. Reason: Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel …. Check the official notice for the remedy. Verify recall #Z-0121-2025 with the FDA Devices before acting.

The recall

Medline Industries, LP - Northfield issued this moderate-severity FDA Devices recall-Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel ….

Moderate
severity level: Class II
classification: October 23, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0121-2025 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

MEDLINE OPEN HEART PACK, REF DYNJ66216C

Reason for recall

Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.

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-0121-2025
Date reported	October 23, 2024
Date initiated	August 28, 2024
Recalling firm	Medline Industries, LP - Northfield
Firm location	Northfield, IL
Affected scope	123 kits
Distribution	US Nationwide distribution.

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-0121-2025) 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? ▼

MEDLINE OPEN HEART PACK, REF DYNJ66216C. Recalled by Medline Industries, LP - Northfield. Units affected: 123 kits.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on October 23, 2024. Severity: Moderate. Recall number: Z-0121-2025.

Where was the recalled product distributed? ▼

Distribution: US Nationwide distribution..

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

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This recall: FDA Devices, reported October 23, 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