CLASS II ONGOING Device recall · Reported 7 May 2025 · FDA Enforcement Report

Medline Sterile 9% Normal Saline recalled by MEDLINE INDUSTRIES, LP

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Sterile 9% Normal Saline, USP, distributed nationwide in the US. The recall was initiated on 19 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 10884389338247 (EA) 10884389338230 (CS), Lot Numbers: 23DJA038, 23DJA070, 23DJA114, 23EJA057, 23EJA128, 23EJA144, 23FJA110, 23GJA041, 23GJA118, 23GJA132, 23HJA033, 23IJA045, 23IJA052, 23IJA102, 23JJA103, 23JJA119, 23JJA144, 23LJA114, 24AJA025, 24AJA061, 24AJA180, 24BJA038, 24BJA092, 24BJA119, 24BJA158, 24CJA048, 24CJA117, 24CJA147, 24DJA010, 24HJA075, 24HJA178, 24KJA148.

Quantity recalled2519991 units

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-1706-2025
FDA event ID: 96630
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 19 Mar 2025
FDA classified: 1 May 2025
Reported: 7 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Other Medical Devices

Timeline

19 Mar 2025	Recall initiated by company
1 May 2025	Classified by FDA	+43 days
7 May 2025	Published in enforcement report	+6 days

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

Reason for recall

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Panama and Canada.

Nationwide

Questions about this recall

Is Medline Sterile 9% Normal Saline, USP recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Sterile 9% Normal Saline, USP on 19 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1706-2025.

Why was it recalled?

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.

Which lots are affected?

UDI/DI 10884389338247 (EA) 10884389338230 (CS), Lot Numbers: 23DJA038, 23DJA070, 23DJA114, 23EJA057, 23EJA128, 23EJA144, 23FJA110, 23GJA041, 23GJA118, 23GJA132, 23HJA033, 23IJA045, 23IJA052, 23IJA102, 23JJA103, 23JJA119, 23JJA144, 23LJA114, 24AJA025, 24AJA061, 24AJA180, 24BJA038, 24BJA092, 24BJA119, 24BJA158, 24CJA048, 24CJA117, 24CJA147, 24DJA010, 24HJA075, 24HJA178, 24KJA148.

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Panama and Canada.

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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