CLASS II ONGOING Device recall · Reported 15 Jul 2026 · FDA Enforcement Report

Medline Convenience Kits: Open Heart Peds Pack recalled

Medline Industries is recalling Medline Convenience Kits: Open Heart Peds Pack, distributed nationwide in the US. The recall was initiated on 28 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) DYNJ88569, UDI-DI: 10198459182334(each), 40198459182335(case), Lot Number: 25ABO124; 2) DYNJ88569, UDI-DI: 10198459182334(each), 40198459182335(case), Lot Number: 24KBT583; 3) DYNJ88569, UDI-DI: 10198459182334(each), 40198459182335(case), Lot Number: 24KBB032; 4) DYNJ88569A, UDI-DI: 10198459309649(each), 40198459309640(case), Lot Number: 25DBF217; 5) DYNJ88569B, UDI-DI: 10198459505669(each), 40198459505660(case), Lot Number: 25JBP861; 6) DYNJ88569C, UDI-DI: 10198459585876(each), 40198459585877(case), Lot Number: 26ABE456; 7) DYNJ88569C, UDI-DI: 10198459585876(each), 40198459585877(case), Lot Number: 25KBI025

Quantity recalled396 kits

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-2697-2026
FDA event ID: 99196
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 28 May 2026
FDA classified: 8 Jul 2026
Reported: 15 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

28 May 2026	Recall initiated by company
8 Jul 2026	Classified by FDA	+41 days
15 Jul 2026	Published in enforcement report	+7 days

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

Reason for recall

Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9 due to an error in its distribution control process.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART PEDS PACK, Model Number: DYNJ88569A; 3) OPEN HEART PEDS PACK, Model Number: DYNJ88569B; 4) OPEN HEART PEDS PACK, Model Number: DYNJ88569C

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Medline Convenience Kits: Open Heart Peds Pack recalled?

Yes. Medline Industries recalled Medline Convenience Kits: Open Heart Peds Pack on 28 May 2026. The recall is Class II and its status is Ongoing. Recall number Z-2697-2026.

Why was it recalled?

Which lots are affected?

1) DYNJ88569, UDI-DI: 10198459182334(each), 40198459182335(case), Lot Number: 25ABO124; 2) DYNJ88569, UDI-DI: 10198459182334(each), 40198459182335(case), Lot Number: 24KBT583; 3) DYNJ88569, UDI-DI: 10198459182334(each), 40198459182335(case), Lot Number: 24KBB032; 4) DYNJ88569A, UDI-DI: 10198459309649(each), 40198459309640(case), Lot Number: 25DBF217; 5) DYNJ88569B, UDI-DI: 10198459505669(each), 40198459505660(case), Lot Number: 25JBP861; 6) DYNJ88569C, UDI-DI: 10198459585876(each), 40198459585877(case), Lot Number: 26ABE456; 7) DYNJ88569C, UDI-DI: 10198459585876(each), 40198459585877(case), Lot Number: 25KBI025

Where was it sold?

US Nationwide distribution.

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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9 Sep 2026Device	CLASS II	Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries	Medline Industries	Sterility	Nationwide
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9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ortho Aspiration Kit recalled	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Arterial Line Insertion Kit recalled	Medline Industries	Sterility	Nationwide

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Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ortho Aspiration Kit recalled	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Arterial Line Insertion Kit recalled	Medline Industries	Sterility	Nationwide