Quick Facts at a Glance
- Recall Date
- December 16, 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
- Suction Irrigator Kits
- Model numbers
- REF CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25FBK870, Lot Number 25EBD110, REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25EBC253, Lot Number 25DBG393, REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25FBQ303 +7 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 16, 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 containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
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
Medline medical procedure kits are designed for various surgical applications and are essential for medical professionals during procedures. These kits contain various tools and devices necessary for surgeries.
Why This Is Dangerous
The Strykeflow 2 Suction Irrigator's design flaw allows saline to leak into areas that could cause electrical issues, creating burn risks or other hazards during surgeries.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a significant number of medical kits, potentially disrupting surgical procedures and requiring immediate attention from healthcare providers.
Practical Guidance
How to identify if yours is affected
- Check the model number against the recalled list.
- Inspect the kit packaging for UDI/DI codes.
- Verify the lot number if available.
Where to find product info
Model numbers and lot numbers can typically be found on the packaging and the product itself.
What timeline to expect
Expect to receive refund or replacement instructions within 4-6 weeks after contacting Medline.
If the manufacturer is unresponsive
- Document all communication attempts with Medline.
- Contact the FDA for further assistance if necessary.
- Consult a consumer protection agency.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Verify the safety certifications of medical tools before purchase.
- Stay informed on design changes for medical devices.
Documentation advice
Keep records of your purchase, any correspondence with Medline, and photographs of the product.
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Product Details
The recall includes 33 models of medical procedure convenience kits, including WCH BARI-GASTRECTOMY and ROBOTIC PROCEDURE kits. These kits were distributed nationwide in the U.S. and contain the Strykeflow 2 Suction Irrigator.
Key Facts
- Recall date: December 16, 2025
- Report date: January 21, 2026
- Class II recall
- Total units recalled: 4,536
- Nationwide distribution in the U.S.
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