Recall Z-0107-2027— POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC

Name: FDA recall Z-0107-2027
Creator: U.S. Food and Drug Administration
Published: 2026-08-25

Class II · Ongoing

Class II FDA medical device recall by POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC, initiated 2026-08-25. It names one FDA 510(k) clearance: K840500. Product: SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;. Reason: 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)..

Recalling firm: POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-08-25
Firm location: Cortlandt Manor, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K840500 — SEDIPLASTPrecision Technology, Inc.·cleared 1984-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.