Quick Facts at a Glance
- Recall Date
- November 26, 2025
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medline Industries, LP
- Product type
- IV Administration Sets
- Model numbers
- Medline kit SKU PHS972096014B UDI/DI: 10889942695911 (EA) 40889942695912 (CS), Lot Number 25IBT843, Medline kit SKU CDS984289O UDI/DI: 10198459418143 (EA) 40198459418144 (CS), Lot Number 25IMA327, Medline kit SKU DYNJ903523F UDI/DI: 10198459316593 (EA) 40198459316594 (CS), Lot Number 25IMI028.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 26, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
About This Product
The Medline Deluxe Pre Op Kit is commonly used in medical settings to prepare patients for surgery. It typically includes various essential medical supplies, including IV administration sets.
Why This Is Dangerous
The kits contain IV administration sets with check valves that may malfunction. When stuck, these valves can lead to improper medication delivery, posing serious risks to patient health.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must act quickly to ensure safety. The high risk associated with this malfunction could lead to severe health consequences.
Practical Guidance
How to identify if yours is affected
- Check the SKU numbers on your Medline kit packaging.
- Confirm if the SKU matches DYKS2034A or DYKS2006B.
- Look for any notifications from Medline regarding this recall.
Where to find product info
SKU numbers can typically be found on the product box or labeling.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing after submitting your request.
If the manufacturer is unresponsive
- Document your communication attempts with Medline.
- Try reaching out via different contact methods, such as email or phone.
- Consider filing a complaint with the appropriate regulatory agency if issues persist.
How to prevent similar issues
- When purchasing medical devices, always check for the latest recalls and safety alerts.
- Look for devices with reliable safety certifications.
- Consult healthcare professionals for recommended products.
Documentation advice
Keep records of your purchase, any communication with Medline, and photos of the product as evidence.
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Product Details
The recall involves Medline Deluxe Pre Op Kits with SKU DYKS2034A and DYKS2006B. These kits contain B. Braun IV Administration Sets and Pump Administration Sets. The affected products were distributed nationwide.
Key Facts
- Recall date: November 26, 2025
- Class II recall classification
- 32 units recalled nationwide
- Stop using the device immediately
- Contact healthcare provider for instructions
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Safety Guide
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