High FDA (Devices)·Z-3297-2026·Announced 2026-10-07

Cardinal Health Recalls Gynecological Laparoscopy Kits Due to Handpiece Leakage

Cardinal Health 200, LLC is recalling 2,957 gynecological laparoscopy kits because the handpieces may leak fluid, creating a slip and fall hazard.

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: The recall is classified as FDA Class II and involves a risk of harm (slip and fall) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Cardinal Health 200, LLC is recalling 2,957 Presource Packs containing Stryker StrykeFlow PS and AHTO tube sets. These kits are used for gynecological laparoscopy and robotic procedures. The recall involves specific catalog numbers and lot numbers, including PB23GLNLAC, PB23GLNLA1, PB23GLNLA2, PB23GLNLA3, PB23GLNLA4, PB23GRNLD, PB23GRNLE, PB23GRNL5, PB23GRNL6, and SOTDKGREFB.

The recall is being conducted because the tube sets contain handpieces that may leak during use. This fluid leakage can pool on the floor, creating a potential slip and fall hazard for users. The impact of the defect ranges from user dissatisfaction to the risk of injury from slipping.

The affected kits were distributed nationwide in the states of California, Illinois, Kentucky, Missouri, North Carolina, New York, Ohio, and Texas. Users should check their inventory for the specific catalog numbers and lot numbers listed in the recall notice and stop using any affected kits. The FDA has classified this as a Class II recall.

The recalled product

Product: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC; 2) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA1; 3) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA2; 4) KIT, GYN…
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Kits
Hazard: slip-fall
fluid-leakage
Affected units: 2,957

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)

1) PB23GLNLAC
UDI-DI: 10197106760901(each)
50197106760909(case)
Lot Number: 24317FG2
2) PB23GLNLAC
Lot Number: 24347FG2
3) PB23GLNLAC
Lot Number: 24355FG2
4) PB23GLNLAC
Lot Number: 25069FG2
5) PB23GLNLAC
Lot Number: 25014FG2
6) PB23GLNLAC
Lot Number: 25029FG2
7) PB23GLNLA1
UDI-DI: 10197106809969(each)
50197106809967(case)
Lot Number: 20
8) PB23GLNLA2
UDI-DI: 10198956053328(each)

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Same manufacturer · Cardinal Health 200, LLC

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Cardinal Health Recalls Presource Packs with Leaking Handpieces
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Cardinal Health Recalls Stryker StrykeFlow PS and AHTO Tube Set Kits
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Cardinal Health Recalls Presource Packs Due to Potential Handpiece Leakage
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Same hazard · slip fall