TemporaryFDAOngoing
Can cause harm that is usually temporary.
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
Check the device or its packaging for
Model/Catalog No. S-100 and S-1000; UDI-DI: N/A; Lot Number E1150A; Expiration Date 06/30/27
- Why
- 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).
- Distributed
- 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.
- Company
- POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0107-2027 · retrieved 7 October 2026
Read the official notice