Quick Facts at a Glance
- Recall Date
- December 16, 2025
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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
- 1) UDI/DI 10198459269196 (EA) 40198459269197 (CS), Lot Number 25EBD732, 2) UDI/DI 10198459326318 (EA) 40198459326319 (CS), Lot Number 25FBA103.
- Sold at
- Unknown
- 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
The Medline medical procedure convenience kits are designed to assist healthcare providers during surgical procedures. They typically include necessary tools and devices for efficient medical care.
Why This Is Dangerous
The Strykeflow 2 Suction Irrigator's design flaw allows saline to leak into the handpiece and battery pack, which can cause electrical issues and vapor emissions that may resemble smoke.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using these kits immediately to avoid potential electrical hazards and ensure safety during medical procedures.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the kit packaging or documentation.
- Verify if the model number matches DYNJ908777B or DYNJ911359.
- Check for any signs of leakage or vapor emissions during use.
Where to find product info
Model numbers can typically be found on the packaging, user manual, or on the device itself.
What timeline to expect
Expect a refund processing timeline of approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Contact Medline again using different communication methods.
- Document all interactions for reference.
- Consider escalating the issue through relevant health authorities.
How to prevent similar issues
- Always verify product recalls before use, especially for medical devices.
- Check for safety certifications and manufacturer updates.
- Stay informed about design changes in medical devices.
Documentation advice
Keep copies of receipts, recall notifications, and any correspondence with the manufacturer as evidence.
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Product Details
The recall includes the following models: 1) THORACIC ROBOTICS, REF DYNJ908777B and 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359. The kits were distributed nationwide in the United States.
Key Facts
- Affected models include DYNJ908777B and DYNJ911359
- High hazard classification due to potential leaks
- Stop using affected kits immediately
- Contact Medline for further instructions
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