Class IIDeviceOngoing

POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC

SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;

Reason for recall

During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to a biological hazard (blood).

Details

Recall number: Z-0107-2027
Event ID: 99810
Recall initiated: Aug 25, 2026
Classified: Oct 7, 2026
Reported: Oct 14, 2026
Quantity: 448400
Distribution: Worldwide - US Nationwide distribution in the states and territory of AK, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the country of United Kingdom.
Initiated by: Voluntary: Firm initiated
Firm notification: E-Mail
Firm location: Cortlandt Manor, NY, United States
Lot / code info: Model/Catalog No. S-100 and S-1000; UDI-DI: N/A; Lot Number E1150A; Expiration Date 06/30/27