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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Medline VALVE PACK-LF Kits Recalled for Catheter Shape Defect

Agency Publication Date: October 1, 2025
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Summary

Medline Industries, LP is recalling 828 units of Medline VALVE PACK-LF kits because they contain cannula products with catheters that may not retain their intended shape. The recall affects kits with model numbers DYNJ0415366P and DYNJ0415366Q. Healthcare providers and clinical facilities should stop using these kits immediately and contact the manufacturer or their distributor to arrange for a return or replacement.

Risk

The catheter component may fail to hold its shape during use, which can lead to procedural difficulties, medical delays, or ineffective treatment during clinical procedures.

What You Should Do

  1. This recall affects Medline VALVE PACK-LF kits (model numbers DYNJ0415366P and DYNJ0415366Q) containing specific lots of cannula products where the catheter may not retain its shape.
  2. Check your kit for model number DYNJ0415366P with lot number 24DMG366, or model number DYNJ0415366Q with lot numbers 25EMD672, 25GMD016, 25AMB610, 25BMJ241, 25CMI425, 24DMC189, 24EMC463, 24GMJ353, 24IMB824, or 24KME116.
  3. Stop using the recalled medical kits immediately and remove them from clinical inventory.
  4. Contact Medline Industries, LP or your medical supply distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline Kits: VALVE PACK-LF (DYNJ0415366P)
Model / REF:
DYNJ0415366P
Lot Numbers:
24DMG366
UDI:
10195327177966
40195327177967

Includes UDI-DI 10195327177966 for individual units and 40195327177967 for cases.

Product: Medline Kits: VALVE PACK-LF (DYNJ0415366Q)
Model / REF:
DYNJ0415366Q
Lot Numbers:
25EMD672
25GMD016
25AMB610
25BMJ241
25CMI425
24DMC189
24EMC463
24GMJ353
24IMB824
24KME116
UDI:
10195327678227
40195327678228

Includes UDI-DI 10195327678227 for individual units and 40195327678228 for cases.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97555
Status: Active
Manufacturer: Medline Industries, LP
Sold By: Medical supply distributors
Manufactured In: United States
Units Affected: 828 units
Distributed To: California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.