CLASS II ONGOING Device recall · Reported 7 May 2025 · FDA Enforcement Report
Medline Sterile 0.9% Normal Saline recalled by MEDLINE INDUSTRIES, LP
Medline Industries LP - Northfield is recalling Medline Sterile 0.9% 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
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.
Questions about this recall
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 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
9 other products · FDA event 96630This product is part of a recall event; the main page for the event is Medline procedure kits, labeled as: T AND A PACK -LF recalled.
More recalls from Medline Industries LP - Northfield
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|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
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