HIGH

Medline Recalls Medical Procedure Kits Due to Leakage Risk

Medline Industries recalled 12,584 medical procedure convenience kits on December 16, 2025. The recall stems from design changes in Stryker's Strykeflow 2 Suction Irrigators that can lead to leaks or vaporized saline emissions. Healthcare providers and patients must stop using the devices immediately and follow the recall instructions.

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 12,584 medical procedure convenience kits, including multiple reference numbers. These kits were distributed nationwide in the United States and were available through various healthcare providers.

The Hazard

A design change in the Strykeflow 2 Suction Irrigator allows irrigation solution to leak into the handpiece and battery pack. This can cause devices to emit vaporized saline, resembling smoke, which poses a burn risk.

Reported Incidents

The recall does not mention any reported injuries or deaths. However, the risk associated with leaking devices is classified as high.

What to Do

Stop using the affected kits immediately. Contact Medline Industries for recall instructions and return procedures.

Contact Information

Reach Medline Industries at 1-800-396-6665 or visit their website for more information on the recall.

Key Facts

  • Recall date: December 16, 2025
  • Total kits recalled: 12,584
  • No injuries or deaths reported
  • High hazard classification

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
BURN

Product Classification

Product TypeMedical Procedure Convenience Kits
Sold At
Multiple Retailers

Product Details

Model Numbers
REF CDS980523M: UDI/DI 10195327508913 (EA) 40195327508914 (CS)
Lot number 25FBF036
Lot number 25DBB218
REF CDS980647K: UDI/DI 10195327508920 (EA) 40195327508921 (CS)
Lot number 25DBP829
+11 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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