HIGH

Medline Medical Kits Recalled Due to Suction Irrigator Hazards

Medline recalled 41,432 medical procedure convenience kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak or emit vaporized saline. This defect poses a high risk of injury during medical procedures.

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'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

  1. Check the model numbers listed in the recall notice.
  2. Verify the lot numbers against those specified in the recall.
  3. 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.

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
  • 41,432 units recalled
  • Class II recall due to high hazard level
View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

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

Product Classification

Product TypeSuction Irrigator Kits
Sold At
Multiple Retailers

Product Details

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
+9 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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