CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

Medline convenience kits labeled as: C-section, Medline Kit recalled

Medline Industries is recalling Medline convenience kits labeled as: C-section, Medline Kit, distributed nationwide in the US. The recall was initiated on 10 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMedline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case), Lot Number 26FMC710; Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case), Lot Number 26DMG417; Medline Kit SKU DYNJ911755, UDI/DI 10198459523946 (each) 40198459523947 (case), Lot Number 25KMI628; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 26ABJ549; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 26ABI899; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 25LBT433.

Quantity recalled106 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-3026-2026
FDA event ID: 99507
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 10 Jul 2026
FDA classified: 26 Aug 2026
Reported: 2 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Jul 2026	Recall initiated by company
26 Aug 2026	Classified by FDA	+47 days
2 Sep 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

Kits contain a potentially contaminated component which were recalled by the manufacturer

Product as listed by the FDA

Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C-SECTION, Medline Kit SKU DYNJ911755; 3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014.

Where it was distributed

US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.

Nationwide Alabama California Florida Illinois Kansas Louisiana Massachusetts Maryland Missouri Mississippi Montana Nevada New York Ohio Oklahoma South Carolina Texas Wisconsin

Questions about this recall

Is Medline convenience kits labeled as: C-section, Medline Kit recalled?

Yes. Medline Industries recalled Medline convenience kits labeled as: C-section, Medline Kit on 10 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-3026-2026.

Why was it recalled?

Kits contain a potentially contaminated component which were recalled by the manufacturer

Which lots are affected?

Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case), Lot Number 26FMC710; Medline Kit SKU DYNJ904612L, UDI/DI 10198459495625 (each) 40198459495626 (case), Lot Number 26DMG417; Medline Kit SKU DYNJ911755, UDI/DI 10198459523946 (each) 40198459523947 (case), Lot Number 25KMI628; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 26ABJ549; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 26ABI899; Medline Kit SKU DYNJ912014, UDI/DI 10198459599569 (each) 40198459599560 (case), Lot Number 25LBT433.

Where was it sold?

US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.

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
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

Other Other Medical Devices recalls

All 13,771

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