Official recall notice

FDA DeviceClass IINotable

Sediplast Recall (Oct 2026) – POLYMEDCO

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

Recall date
2026-10-14
FDA class
Class II

Why it was recalled

Hazard

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).

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Product description

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).

Affected products

Model/Catalog No. S-100 and S-1000; UDI-DI: N/A; Lot Number E1150A; Expiration Date 06/30/27

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