Fresenius 10ML Syringe Recall: Blood Backfill Leakage Risk

Take action

Contact the company & request your remedy

Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920, N/A · Waltham, MA 02451-1521

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

Fresenius Medical Care is recalling 10ML syringes with a Luer lock and needle (Part Number 15-10ML-0) due to a potential for blood backfill leakage and foreign material. This could lead to contamination or infection risks during medical procedures.

Why it’s dangerous

The syringe design may allow blood to leak back into the syringe during use, potentially introducing foreign material. This could cause contamination or infection if the syringe is reused or improperly handled.

Who’s affected

Healthcare professionals and patients using these syringes for medical injections may be affected. Those with specific medical conditions requiring precise injections are at higher risk.

How to tell if you have this one

Check for the Part Number 15-10ML-0 on the syringe packaging. All lots of this product are affected, including those sold with the UDI-DI: 16945060500125.

Brand
Fresenius Medical Care
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the Part Number 15-10ML-0 on the syringe packaging to confirm if it is affected.

✎ GovInfoNow

Questions people ask

Is this recall affecting all syringes?

Yes, all lots of Part Number 15-10ML-0 are affected.

What should I do if I have this syringe?

The recall record does not specify a remedy, so check with the manufacturer for further instructions.

How can I tell if my syringe is affected?

Look for the Part Number 15-10ML-0 on the packaging; all lots of this product are affected.

Take action

Contact Fresenius Medical Care

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

✉️ Open in email

Subject: Recall Z-0006-2024 — Fresenius Medical Care Fresenius Medical Care

Hello,

I own a Fresenius Medical Care that is covered by recall Z-0006-2024 from Fresenius Medical Care.

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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-0006-2024 (August 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0006-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.

Fresenius Medical Care Holdings, Inc. recalls 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

Lower-risk recall