FDA Device recall Z-0107-2027
SEDIPLAST
- FDA Device
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of SEDIPLAST by Polymedco Polymedco Cancer Diagnostic Products, citing 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 f….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0107-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-25 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Polymedco Polymedco Cancer Diagnostic Products |
| Distribution | US |
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).
Identifiers
| code_info | Model/Catalog No. S-100 and S-1000; UDI-DI: N/A; Lot Number E1150A; Expiration Date 06/30/27 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0107-2027%22
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