Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number:
Summary
The FDA issued a Class II for Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GY by Cardinal Health 200, LLC. Reason: The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand.
Details
Source
Device Recall
External ID
Z-3297-2026
Action Date
2026-10-07
Status
Ongoing
Category
device
Product Description
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 LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA3; 5) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA4; 6) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNLD; 7) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNLE; 8) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNL5; 9) KIT, GYN ROBOTIC NEW HAN , Catalog Number: PB23GRNL6; 10) MVHS GU GYN ROBOT PACK , Catalog Number: SOTDKGREFB
Lot/Code Info: 1) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 24317FG2 ; 2) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 24347FG2 ; 3) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 24355FG2 ; 4) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 25069FG2 ; 5) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 25014FG2 ; 6) PB23GLNLAC, UDI-DI: 10197106760901(each), 50197106760909(case), Lot Number: 25029FG2 ; 7) PB23GLNLA1, UDI-DI: 10197106809969(each), 50197106809967(case), Lot Number: 20 ; 8) PB23GLNLA2, UDI-DI: 10198956053328(each), 50198956053326(case), Lot Number: 24317FG2 ; 9) PB23GLNLA3, UDI-DI: 10198956066847(each), 50198956066845(case), Lot Number: 24309FG2 ; 10) PB23GLNLA3, UDI-DI: 10198956066847(each), 50198956066845(case), Lot Number: 24317FG2 ; 11) PB23GLNLA3, UDI-DI: 10198956066847(each), 50198956066845(case), Lot Number: 24325FG2 ; 12) PB23GLNLA4, UDI-DI: 10198956072664(each), 50198956072662(case), Lot Number: 24317FG2 ; 13) PB23GLNLA4, UDI-DI: 10198956072664(each), 50198956072662(case), Lot Number: 24325FG2 ; 14) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24353FG2 ; 15) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24355FG2 ; 16) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24317FG2 ; 17) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24353FG2 ; 18) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24353FG2 ; 19) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25029FG2 ; 20) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25045FG2 ; 21) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 24317FG2 ; 22) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25065FG2 ; 23) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25062FG2 ; 24) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25085FG2 ; 25) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25097FG2 ; 26) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25101FG2 ; 27) PB23GRNLD, UDI-DI: 10197106968963(each), 50197106968961(case), Lot Number: 25148FG2 ; 28) PB23GRNLE, UDI-DI: 10198956320178(each), 50198956320176(case), Lot Number: 25217FG2 ; 29) PB23GRNL5, UDI-DI: 10198956050419(each), 50198956050417(case), Lot Number: 24325FG2 ; 30) PB23GRNL6, UDI-DI: 10198956067806(each), 50198956067804(case), Lot Number: 24299FG2 ; 31) PB23GRNL6, UDI-DI: 10198956067806(each), 50198956067804(case), Lot Number: 24317FG2 ; 32) PB23GRNL6, UDI-DI: 10198956067806(each), 50198956067804(case), Lot Number: 24325FG2 ; 33) SOTDKGREFB, UDI-DI: 10198956112766(each), 50198956112764(case), Lot Number: 25154FG2
Quantity Affected: 2957 kits
Reason for Recall
The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.
Distribution
US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-18
Company
Waukegan, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 518 device-related FDA actions this month.
Cardinal Health 200, LLC has 168 FDA actions in our database, including 167 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cardinal Health 200, LLC have FDA actions?
Cardinal Health 200, LLC has 168 FDA actions in our database, including 167 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3297-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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