Class II U.S. Food and Drug Administration

Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC Sediplast recall: During use of an affected tube, the operator may encounter increased

Recall published 11 days ago

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).

The hazard: Impact or projectile hazard

This product can throw a part or strike the user, which is why the recall is phrased as an impact hazard rather than a breakage complaint.

What the notice says: 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).

Why it matters: The product can throw a part, release stored energy unexpectedly or strike the user. Eye injuries are the common outcome, and they are frequently permanent.

Symptoms and when to call a doctor

For an eye injury, do not rub the eye and do not try to remove anything embedded in it. Cover the eye with a shield that does not press on it — the bottom of a paper cup taped in place works — and get to an emergency department. For a blow to the head, watch for worsening headache, repeated vomiting, confusion or drowsiness, and call 911 if any of those appear.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0107-2027
Published
October 14, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC
Product type
Medical devices
Units affected
448400
Distribution
Nationwide
Made in
United States
Lot / code info
Model/Catalog No. S-100 and S-1000; UDI-DI: N/A; Lot Number E1150A; Expiration Date 06/30/27

Products covered by this recall

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

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • E1150A

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 06
  • 30
  • 27 — 448400

Model or item number

On the rating label, the box or the instruction sheet.

  • S-100
  • S-1000

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Impact

Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC — This product can throw a part or strike the user, which is why the recall is phrased as an impact hazard rather than a breakage complaint.

  1. Stop using the product and release any stored tension or pressure if the instructions describe a safe way to do it.
  2. Wear eye protection if you have to handle the item to pack it for return.
  3. Follow the remedy on this page and quote the model and date code from the label.
  4. Keep bystanders, and particularly children, away from it until the remedy is complete.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.
  • If you bought it from a retailer rather than the brand, try both. Target, Walmart and Amazon often refund recalled goods from the order history.
  • If the company stops responding, escalate to the CPSC. Firms under a recall order have reporting duties to the agency.

Company contact: POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC — 510 Furnace Dock Rd, Cortlandt Manor, NY, 10567-6220

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Polymedco, Inc. / Polymedco Cancer Diagnostic Products, LLC… 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). 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code E1150A; best-by date 06 or 30; model number S-100, S-1000. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and release any stored tension or pressure if the instructions describe a safe way to do it.

Can I get my money back?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls