Angiodynamics RS TANDEM 5F DL XCELA PICC PASV Recall: Bacterial Endotoxins Risk

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Recalling firmAngiodynamics Inc. (Navilyst Medical Inc.)10 Glens Falls Tech Park, N/A · Glens Falls, NY 12801-3864

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Angiodynamics is recalling certain PICC line kits due to possible unsafe levels of bacterial endotoxins. This could lead to infections if used improperly in medical procedures.

Why it’s dangerous

The kits may contain unsafe levels of bacterial endotoxins (pyrogens) that could cause infections or fever in patients during medical procedures. This risk is specific to the kits used in catheter placements.

Who’s affected

Healthcare professionals using the RS TANDEM 5F DL XCELA PICC PASV kits for central venous catheter placements are most at risk. Patients receiving these treatments could also be affected.

How to tell if you have this one

Check for the catalog number 60M181582 on the kit packaging. The product was sold with UPN H96560M1815821 and lot number 5299859.

Brand
Angiodynamics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Packaging
Look for catalog number 60M181582 on the kit packaging to confirm if it's affected.

✎ GovInfoNow

Questions people ask

What is the specific risk with these kits?

The kits may contain unsafe levels of bacterial endotoxins (pyrogens) that could cause infections or fever in patients during medical procedures.

How can I tell if I have the recalled product?

Check for catalog number 60M181582 on the kit packaging. The product was sold with UPN H96560M1815821 and lot number 5299859.

What should I do if I have the recalled product?

The recall record does not specify a remedy, so contact Angiodynamics for guidance.

Take action

Contact Angiodynamics

We’ve drafted a message you can send Angiodynamics to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2212-2018 — Angiodynamics Angiodynamics

Hello,

I own a Angiodynamics that is covered by recall Z-2212-2018 from Angiodynamics.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2212-2018 (May 10, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2212-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Angiodynamics Inc. (Navilyst Medical Inc.) recalls RS TANDEM 5F DL XCELA PICC PASV, Catalog Number 60M181582

Lower-risk recall