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
- Medical Procedure Convenience Kits
- Model numbers
- REF CDS980754T: UDI/DI 10198459121814 (EA) 40198459121815 (CS), Lot Number 25EMD795, REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBR237, Lot Number 25EBP591, Lot Number 25DBM353, Lot Number 25CBL184, Lot Number 25BBL633 +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 medical procedure convenience kits are used in various surgical procedures to provide necessary tools and supplies. These kits are essential for healthcare providers to ensure safe and efficient surgeries.
Why This Is Dangerous
The design change in the Strykeflow 2 allows saline to leak into the handpiece and battery pack, potentially leading to burns when the device is in use. This issue arises during medical procedures, increasing risks for both patients and healthcare professionals.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers' ability to perform certain procedures safely, leading to potential delays in treatment for patients. Immediate action is necessary to prevent injury.
Practical Guidance
How to identify if yours is affected
- Locate the model number and lot number on your Medline kit packaging.
- Check against the list of recalled models and lot numbers provided in the recall statement.
- If your kit is among the recalled items, stop using it immediately.
Where to find product info
Model numbers and lot numbers can typically be found on the product packaging or the device itself, usually near the barcode or on the product label.
What timeline to expect
Refund processing may take approximately 4-6 weeks after the return is initiated.
If the manufacturer is unresponsive
- Contact Medline Industries again for follow-up.
- File a complaint with the FDA if the issue persists.
How to prevent similar issues
- When purchasing medical devices, verify the latest safety standards and recalls.
- Stay informed about product updates from manufacturers.
- Ensure all medical devices are certified and come from reputable sources.
Documentation advice
Keep records of all communications with the manufacturer, including emails and phone call notes, as well as copies of any receipts or return shipping labels.
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Product Details
The recall affects the following models: LAVH PROCEDURE (REF CDS980754T), GYN LAP HYSTERECTOMY CDS (REF CDS982662Q), DAVINCI HYSTERECTOMY CDS (REF CDS985344F), and others. The kits were distributed nationwide in the U.S.
Key Facts
- Recall date: December 16, 2025
- Total units recalled: 1,457
- Products distributed nationwide
- Class II recall due to potential burn risk
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Safety Guide
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