The Recall Desk
HighFDA (Devices)·Z-1088-2026·Announced 2026-01-21

Medline Surgical Procedure Kits Recalled Due to Irrigation Solution Leakage

Medline is recalling 12,584 surgical procedure kits containing Stryker Strykeflow 2 irrigators due to a design defect that causes irrigation solution to leak and emit vaporized saline during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The design defect creates a risk of harm through potential exposure to vaporized saline and liquid leakage near electrical components, but no actual injuries have been documented.

Plain-English summary

Medline Industries is recalling 12,584 medical procedure convenience kits containing Stryker Strykeflow 2 Suction Irrigators that are distributed nationwide. These kits are used in surgical procedures.

The recalled devices have a design defect related to a 2024 design change. The defect allows irrigation solution to reach the handpiece and battery pack while the device is in use. As a result, some devices leak or release vaporized saline that may look like smoke.

Healthcare facilities and surgical centers using these kits should stop using them immediately and contact Medline Industries for a replacement or repair. No illnesses or injuries related to this issue have been reported so far.

The recalled product

Product
Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical Irrigation
Hazard
  • leakage
  • vapor-inhalation
  • design-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • Lot number 25CBI860
  • REF CDS980864Q: UDI/DI 10198459121937 (EA) 40198459121938 (CS)
  • Lot number 25EMC533
  • REF CDS981583U: UDI/DI 10195327209766 (EA) 40195327209767 (CS)
  • Lot number 25CBC570
  • REF CDS981583V: UDI/DI 10198459311390 (EA) 40198459311391 (CS)
  • Lot number 25FBK816
  • Lot number 25EBS462
  • REF CDS981826K: UDI/DI 10198459224805 (EA) 40198459224806 (CS)
  • Lot number 25FBH633
  • Lot number 25BBU420
  • REF CDS982377K: UDI/DI 10198459229039 (EA) 40198459229030 (CS)
  • Lot number 25DMI839
  • Lot number 25DMF861
  • Lot number 25CMC823

Distribution

Distributed nationwide across the United States.

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