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

Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2

Pending LLM rewrite. Source: FDA_DEVICE Z-1086-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

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 — Devices

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.

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