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RecallWatchMedical Device Safety
Class IIOngoingZ-2444-2026

Medline Industries, LP recalls Medline convenience kits: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUN…

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: BIB AV FISTULA PACK DYNJ58304B CARDIAC MINOR SURGICOUNT PACK DYNJ56573B ENDOVASCULAR PACK DYNJ29135N EP DEVICE DYNJ65916B FULL LINE ANEURYSM CDS CDS983672P GEN FEM POP #14-RF DYNJ21877W IMPLANT PACK DYNJ39316D OPEN HEART MRNGSD DYNJ58354F PACEMAKER PACK-LF DYNJ0618174N PACEMAKER SETUP PACK DYNJ35761D PACER / CATH LAB PACK-LF DYNJ0972604A PACER CDS CDS983686I PACER PACK DYNJ52059D PK, EP LAB PACEMAKER DYNJ43663A VENOUS ACCESS PACKDYNJ45640B
    UDI-DI 10195327512699
    46 affected lots
    25LBP470DYNJ56573B1019348990366925KBK220DYNJ29135N1019532767475525LMG563DYNJ65916B
    +38 more1019348990204425KBG85225LBB895CDS983672P1019845914913925LBO02726BBB852DYNJ21877W1019532710454225JBW040DYNJ39316D1019845922444725KBH774DYNJ58354F1019532751523225KBI240DYNJ0618174N1019532722734025KBC715DYNJ35761D1019532756537426CBC772DYNJ0972604A1088994240390525LMF965CDS983686I1019348985298126ABE755DYNJ52059D1019532736178525LBQ91726CBE736DYNJ43663A1019348979368026CBB662DYNJ45640B1019348949498325LMJ305

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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