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 CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMH913, Kit Lot Number 25EMC376, Kit Lot Number 25CMJ688, Kit Lot Number 25CME476, REF CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25EBM987, Kit Lot Number 25CBT666 +6 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's medical procedure convenience kits are used in various surgical settings for laparoscopic and bariatric procedures. They include essential tools and devices to assist healthcare professionals during surgery.
Why This Is Dangerous
The Strykeflow 2 Suction Irrigator's design flaw allows irrigation solution to leak into the handpiece and battery pack, creating a potential hazard during use. This can lead to malfunction and risk during critical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall impacts healthcare facilities relying on these kits for surgical procedures, necessitating immediate cessation of use and potential delays in surgeries.
Practical Guidance
How to identify if yours is affected
- Check the model numbers listed in the recall notice.
- Verify the lot numbers against those specified in the recall.
- If unsure, consult a healthcare provider for assistance.
Where to find product info
Model numbers and lot numbers can typically be found on the packaging or the product labels.
What timeline to expect
Expect 4-6 weeks for refund processing after returning the product.
If the manufacturer is unresponsive
- Contact Medline Industries, LP again for follow-up.
- Document all correspondence for your records.
How to prevent similar issues
- When purchasing surgical kits, verify the latest product designs and recalls.
- Ensure the kits are from reputable manufacturers with a history of compliance.
Documentation advice
Keep all receipts, correspondence with the manufacturer, and any evidence of the product's condition.
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Product Details
The recall affects 41,432 kits including various laparoscopic and bariatric procedure kits. They were distributed nationwide in the United States. The kits include models such as REF CDS860235L and REF CDS930223M.
Key Facts
- Recall date: December 16, 2025
- Report date: January 21, 2026
- Class II recall due to high hazard level
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