Santanello Surgical VAMPIRO V5001 Suction Sleeve Recall: Sterility Risk

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Contact the company & request your remedy

Recalling firmSantanello Surgical LLC4664 Hayden Run Rd, N/A · Columbus, OH 43221-5937

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Santanello Surgical is recalling VAMPIRO V5001 minimally invasive poole suction sleeves that may have compromised sterility due to packaging issues. This could lead to infections if used improperly during medical procedures.

Why it’s dangerous

The packaging may not be intact, which could allow contamination. If the sleeve is not sterile when used during surgery, it might cause infections in patients.

Who’s affected

Medical professionals using the VAMPIRO V5001 suction sleeves with 5mm spot suction catheters. Patients undergoing procedures with these instruments are at risk if the sleeves are not sterile.

How to tell if you have this one

Check for the lot number SAN1003 and unique device identifier (UDI) (01)00810805000026(10)SAN0003(17)160205 on the packaging. This product is an accessory for 5mm spot suction catheters.

Brand
Santanel: Surgical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Package Integrity
Inspect the packaging for signs of damage or missing components that might compromise sterility.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates potential sterility risks, so it is not recommended for use until the remedy is applied.

What should I do if I have this product?

The recall does not specify a remedy, so contact Santanello Surgical LLC for guidance on safe handling or disposal.

How can I tell if I have the recalled product?

Look for the lot number SAN1003 and UDI (01)00810805000026(10)SAN0003(17)160205 on the packaging.

Take action

Contact Santanel: Surgical

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

✉️ Open in email

Subject: Recall Z-2237-2019 — Santanel: Surgical Santanel: Surgical

Hello,

I own a Santanel: Surgical that is covered by recall Z-2237-2019 from Santanel: Surgical.

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-2237-2019 (June 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2237-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.

Santanello Surgical LLC recalls VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory instrument to ANY 5mm spot

Lower-risk recall