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RecallWatchMedical Device Safety
Class IIOngoingZ-2418-2026

Medline Industries, LP recalls Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAK…

Medline Industries, LPNorthfield, IL, United StatesReported Jun 24, 2026 · 24 days ago
Legal News Analyst ·

Reason for recall

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DYNJ54238L DYNJT6766 STAZ BASIC VASCULAR DYNJ909794C VASCULAR ACCESS KIT CVI5323A VASCULAR CDSCDS983040M
    UDI-DI 10198459422133
    33 affected lots
    25KBA098CDS840150Y1019845930302925JBW22026BBD028DYNJ56297C1019845951395425LMJ874
    +25 moreDYNJT34541019845932566325KBG761DYNJ33822L1019845938558226AMA072DYNJ900962O1019845945258126CBC302DYNJ54238L1019845944311425LMH549DYNJT67661019845958088825KBM870DYNJ909794C1019845952800225LBF702CVI5323A1019845958203525KBM758CDS983040M1019845957981325KBO68226BBB926

What the firm is doing

Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.

DistributionShow details

US Nationwide distribution. OUS distribution pending.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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