HIGH

Medline Medical Kits Recalled Over Strykeflow 2 Suction Hazard

Medline recalled 4,536 medical procedure kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak and emit vaporized saline. The recall affects various models used in surgeries nationwide.

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

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

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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

  1. Check the model number against the recalled list.
  2. Inspect the kit packaging for UDI/DI codes.
  3. 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.

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.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
BURNOTHER

Product Classification

Product Details

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
+10 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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