HIGH

Medline Recalls Medical Kits Over High Burn Risk

Medline Industries recalled 1,457 medical procedure convenience kits on December 16, 2025. The kits contain Stryker's Strykeflow 2 Suction Irrigators that may leak and emit vaporized saline. Healthcare providers and patients must stop using the devices immediately.

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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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.

The Hazard

A design change in the Strykeflow 2 Suction Irrigator allows irrigation solution to leak into the handpiece and battery pack. This malfunction can result in leaking and the emission of vaporized saline, which may resemble smoke.

Reported Incidents

No specific injuries have been reported in connection with this recall. However, the potential for burns exists due to the malfunction.

What to Do

Patients and healthcare providers should immediately stop using the recalled kits. Contact Medline Industries for further instructions and follow the recall notifications sent via letter.

Contact Information

For more information, contact Medline Industries at 1-800-396-4324 or visit their website at www.medline.com.

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 Assessment

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

Product Classification

Product Details

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

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