CLASS II ONGOING Device recall · Reported 24 Jun 2026 · FDA Enforcement Report

Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled

Medline Industries is recalling Medline convenience kits: Bib AV Fistula Pack DYNJ58304B Cardiac Minor Surgicount Pack, distributed nationwide in the US. The recall was initiated on 27 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDYNJ58304B UDI-DI 10195327512699 Lot 25LBP470 DYNJ56573B UDI-DI 10193489903669 Lot 25KBK220 DYNJ29135N UDI-DI 10195327674755 Lot 25LMG563 DYNJ65916B UDI-DI 10193489902044 Lots 25KBG852 25LBB895 CDS983672P UDI-DI 10198459149139 Lots 25LBO027 26BBB852 DYNJ21877W UDI-DI 10195327104542 Lot 25JBW040 DYNJ39316D UDI-DI 10198459224447 Lot 25KBH774 DYNJ58354F UDI-DI 10195327515232 Lot 25KBI240 DYNJ0618174N UDI-DI 10195327227340 Lot 25KBC715 DYNJ35761D UDI-DI 10195327565374 Lot 26CBC772 DYNJ0972604A UDI-DI 10889942403905 Lot 25LMF965 CDS983686I UDI-DI 10193489852981 Lot 26ABE755 DYNJ52059D UDI-DI 10195327361785 Lots 25LBQ917 26CBE736 DYNJ43663A UDI-DI 10193489793680 Lot 26CBB662 DYNJ45640B UDI-DI 10193489494983 Lot 25LMJ305

Quantity recalled49,654 kits total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2444-2026
FDA event ID: 98951
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 27 Apr 2026
FDA classified: 12 Jun 2026
Reported: 24 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

27 Apr 2026	Recall initiated by company
12 Jun 2026	Classified by FDA	+46 days
24 Jun 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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 PACK DYNJ45640B

Where it was distributed

US Nationwide distribution. OUS distribution pending.

Nationwide

Questions about this recall

Is Medline convenience kits: Bib AV Fistula Pack DYNJ58304B Cardiac Minor Surgicount Pack recalled?

Yes. Medline Industries recalled Medline convenience kits: Bib AV Fistula Pack DYNJ58304B Cardiac Minor Surgicount Pack on 27 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2444-2026.

Why was it recalled?

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

Which lots are affected?

DYNJ58304B UDI-DI 10195327512699 Lot 25LBP470 DYNJ56573B UDI-DI 10193489903669 Lot 25KBK220 DYNJ29135N UDI-DI 10195327674755 Lot 25LMG563 DYNJ65916B UDI-DI 10193489902044 Lots 25KBG852 25LBB895 CDS983672P UDI-DI 10198459149139 Lots 25LBO027 26BBB852 DYNJ21877W UDI-DI 10195327104542 Lot 25JBW040 DYNJ39316D UDI-DI 10198459224447 Lot 25KBH774 DYNJ58354F UDI-DI 10195327515232 Lot 25KBI240 DYNJ0618174N UDI-DI 10195327227340 Lot 25KBC715 DYNJ35761D UDI-DI 10195327565374 Lot 26CBC772 DYNJ0972604A UDI-DI 10889942403905 Lot 25LMF965 CDS983686I UDI-DI 10193489852981 Lot 26ABE755 DYNJ52059D UDI-DI 10195327361785 Lots 25LBQ917 26CBE736 DYNJ43663A UDI-DI 10193489793680 Lot 26CBB662 DYNJ45640B UDI-DI 10193489494983 Lot 25LMJ305

Where was it sold?

US Nationwide distribution. OUS distribution pending.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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