CLASS II ONGOING Device recall · Reported 14 Oct 2026 · FDA Enforcement Report
Sediplast; Model/Catalog Numbers recalled by Polymedco, Inc. / Polymedco
Polymedco, Inc. / Polymedco Cancer Diagnostic Products is recalling Sediplast; Model/Catalog Numbers: S-100 and S-1000, distributed nationwide in the US. The recall was initiated on 25 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0107-2027
- FDA event ID
- 99810
- Recalling firm
- Polymedco, Inc. / Polymedco Cancer Diagnostic Products, Cortlandt Manor, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Aug 2026
- FDA classified
- 7 Oct 2026
- Reported
- 14 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 25 Aug 2026 | Recall initiated by company | |
| 7 Oct 2026 | Classified by FDA | +43 days |
| 14 Oct 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
Where it was 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.
Nationwide AlaskaArkansasArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippi
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
Model/Catalog No. S-100 and S-1000; UDI-DI: N/A; Lot Number E1150A; Expiration Date 06/30/27
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Polymedco, Inc. / Polymedco Cancer Diagnostic Products
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | OC-Auto Fobt-chek Negative Controls is the negative recalled | Polymedco, Inc. / Polymedco Cancer Diagnostic Products | Labeling Errors | 47 states |
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| Device | CLASS II | Pathfast Myoglobin II reagent cartridge recalled | Polymedco, Inc.,/Polymedco Cancer Diagnostic Products | Packaging Defects | 8 states |
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