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

Robotic and gynaecology kits recalled over leaking suction irrigators inside

Medline is recalling 12,584 procedure 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 by Medline Industries, LP, covering Robotic (REF CDS980523M), Robotic GYN (CDS980647K), DaVinci Procedure (CDS980864Q) and GYN-URO Lapscp CDS-LF (CDS981583U and CDS981583V) 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 12,584 units, with REF numbers, UDI/DI codes and 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) 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 — Procedure kit
Hazard
Affected units
12,584

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.

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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