The Recall Desk
ModerateFDA (Devices)·Z-1086-2026·Announced 2026-01-21

Laparoscopy kits recalled over suction irrigators that can leak during use

Medline is recalling 41,432 laparoscopy convenience kits containing Stryker Strykeflow 2 Suction Irrigators, which can leak or emit vaporized saline during use.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record cites leakage and vapour emission from a kit component with no stated patient harm or reported injury.

Plain-English summary

Medline medical procedure convenience kits are being recalled, covering Laparoscopy CDS-LF (REF CDS860235L), General Laparoscopic (CDS930223M), Lap Chole CDS (CDS983678K), Laparoscopy Pelv CDS (CDS983679K) and Lap Chole CDS-LF among the kits listed in the enforcement record.

The kits contain Stryker's Strykeflow 2 Suction Irrigators. The record states that 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, and that this design change has caused some devices to leak and/or emit vaporized saline, which can resemble smoke, during use.

The record lists 41,432 units, with REF numbers, UDI/DI codes and kit lot numbers recorded in the enforcement record. Distribution was nationwide in the United States. The FDA has classified the action as Class II.

The record describes leakage and vapour emission and states no further consequence or reported injuries. Facilities should quarantine affected kits and follow Medline's instructions.

The recalled product

Product
Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE CDS-LF,
Manufacturer
Medline Industries, LP
Category
Medical Device — Procedure kit
Hazard
Affected units
41,432

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 CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS)
  • Kit Lot Number 25EMH913
  • Kit Lot Number 25EMC376
  • Kit Lot Number 25CMJ688
  • Kit Lot Number 25CME476
  • REF CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS)
  • Kit Lot Number 25EBM987
  • Kit Lot Number 25CBT666
  • REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS)
  • Kit Lot Number 25FBP815
  • Kit Lot Number 25EBN002
  • Kit Lot Number 25CBN212
  • REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS)
  • Kit Lot Number 25FBN760
  • Kit Lot Number 25EBD329
  • Kit Lot Number 25DBN040
  • Kit Lot Number 25DBK313
  • Kit Lot Number 25CBE452
  • REF CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS)
  • Kit Lot Number 25DMH793

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

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