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

Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled

Medline Industries is recalling Medline convenience kits: Loop Pack DYNJ61460C Open Heart CDS840150Y Pacemaker DYNJ56297C, 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 codesDYNJ61460C UDI-DI 10198459422133 lot 25KBA098 CDS840150Y UDI-DI 10198459303029 lots 25JBW220 26BBD028 DYNJ56297C UDI-DI 10198459513954 lot 25LMJ874 DYNJT3454 UDI-DI 10198459325663 lot 25KBG761 DYNJ33822L UDI-DI 10198459385582 lot 26AMA072 DYNJ900962O UDI-DI 10198459452581 lot 26CBC302 DYNJ54238L UDI-DI 10198459443114 lot 25LMH549 DYNJT6766 UDI-DI 10198459580888 lot 25KBM870 DYNJ909794C UDI-DI 10198459528002 lot 25LBF702 CVI5323A UDI-DI 10198459582035 lot 25KBM758 CDS983040M UDI-DI 10198459579813 lots 25KBO682 26BBB926
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-2418-2026
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

Timeline

27 Apr 2026Recall initiated by company
12 Jun 2026Classified by FDA+46 days
24 Jun 2026Published 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: 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 CDS CDS983040M

Where it was distributed

US Nationwide distribution. OUS distribution pending.

Nationwide

Questions about this recall

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?

DYNJ61460C UDI-DI 10198459422133 lot 25KBA098 CDS840150Y UDI-DI 10198459303029 lots 25JBW220 26BBD028 DYNJ56297C UDI-DI 10198459513954 lot 25LMJ874 DYNJT3454 UDI-DI 10198459325663 lot 25KBG761 DYNJ33822L UDI-DI 10198459385582 lot 26AMA072 DYNJ900962O UDI-DI 10198459452581 lot 26CBC302 DYNJ54238L UDI-DI 10198459443114 lot 25LMH549 DYNJT6766 UDI-DI 10198459580888 lot 25KBM870 DYNJ909794C UDI-DI 10198459528002 lot 25LBF702 CVI5323A UDI-DI 10198459582035 lot 25KBM758 CDS983040M UDI-DI 10198459579813 lots 25KBO682 26BBB926

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

Other products in this recall event

33 other products · FDA event 98951

This product is part of a recall event; the main page for the event is Medline convenience kits: Cmh Central Line Dressing Change recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIMedline convenience kits: Cmh Central Line Dressing Change recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Davinci Main DYNJ908031D recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Acd DYNJ904999J Acdf DYNJ907336B recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Davinci DYNJ905836D Davinci-lf recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIBlock Tray Dynjra2119a Indwelling Nerve Block Dynjra1011a recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: WT Lavh Pack DYNJ46609F recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kit: Smsc-pelviscopy Pack-lf DYNJ0161619M recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kit: Hernia Repair Tote DYNJ908337D recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMinor Cath Lab Pack Dynj84775a Or Vascular Angio Pack recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kit: Labor & Delivery C-section DYNJ907895F recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline EBSI Kit EBSI1534 recalled by Medline IndustriesMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: C-section Kit DYNJ904305J recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Driveline Management Kit EBSI1688 recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Breast-hernia-port Cds-lf CDS984853L recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline CCI Nerve Block Tray DYNJRA2742 Medline CPNB DYNJRA2716 recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Add-a-cath Arterial Insertion recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Bib AV Fistula Pack DYNJ58304B recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Hysterectomy Pack-lf DYNJ20485L recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Breast Imaging DYNJT5893 Chog recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Inpatient Central LN Drsg Kit recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: C Section CDS985505G C Section recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Basic DYNJ905869G Basic Pack recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kit: IV Start Kit W/Hubguard DYNDV2662 recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Femoral Block Tray DYNJRA1739B recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IICenturion convenience kits: Central Line Dressing SV43 Fcp recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Abd Pack DYNJ81673B Bariatric recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kit: Bhs Neuro DYNJ904900N Medtrx Neuro recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Discectomy Pack DYNJ86476B Ear recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kit: Kit: Dressing Change Ped DYNDC3359 recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Basic Eye DYNJ905154I Tubal recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: CVC Insertion KIT ECVC6805B recalledMedline IndustriesDevice MalfunctionNationwide
CLASS IIMedline convenience kits: Port A Cath DYNJ906818A recalledMedline IndustriesDevice MalfunctionNationwide

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DeviceCLASS IIMedline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalledMedline IndustriesDevice MalfunctionNationwide
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