- Recalling firm
- Cardinal Health 200, LLC
- 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.
- Affected products (lot / model / serial)
- 1) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 24317FG2 ; 2) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 24353FG2 ; 3) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 24317FG2 ; 4) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 25069FG2 ; 5) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 25045FG2 ; 6) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 25069FG2 ; 7) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 24353FG2 ; 8) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 25101FG2 ; 9) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 25148FG2 ; 10) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 25217FG2 ; 11) PGVMDVB26, UDI-DI: 10198956007796(each), 50198956007794(case), Lot Number: 24309FG2 ; 12) PGVMDVB27, UDI-DI: 10198956054714(each), 50198956054712(case), Lot Number: 24325FG2 ; 13) PGVMDVB28, UDI-DI: 10198956079847(each), 50198956079845(case), Lot Number: 24317FG2 ; 14) PGVMDVB28, UDI-DI: 10198956079847(each), 50198956079845(case), Lot Number: 24325FG2 ; 15) PGVMDVB29, UDI-DI: 10198956094024(each), 50198956094022(case), Lot Number: 24317FG2 ; 16) PGVMDVB29, UDI-DI: 10198956094024(each), 50198956094022(case), Lot Number: 24348FG2 ; 17) SBA73CLKFD, UDI-DI: 10197106633960(each), 50197106633968(case), Lot Number: 25055FG2 ; 18) SBA73CLK26, UDI-DI: 10198956029828(each), 50198956029826(case), Lot Number: 24309FG2
- Units affected
- 344 kits
- Distribution pattern
- US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
- Firm location
- Waukegan, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3296-2026
- Recall initiated
- August 18, 2026
- FDA classification date
- September 25, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99768
- Last updated on HTM Vibe
- October 13, 2026
