Datascope YAMATO PLUS-R 7.5Fr IAB Kit Recall: Potential Endotoxin Contamination Risk

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Contact the company & request your remedy

Recalling firmDatascope Corporation15 Law Dr, N/A · Fairfield, NJ 07004-3206

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

Datascope is recalling certain YAMATO PLUS-R 7.5Fr 35cc IAB kits sold in Japan because they may contain endotoxins. This could cause infections or other health issues if used in medical procedures.

Why it’s dangerous

Endotoxins are bacterial components that can cause infections or adverse reactions when introduced into the body during medical procedures. The potential contamination in these specific kits could lead to health complications for patients.

Who’s affected

Medical professionals using the recalled YAMATO PLUS-R 7.5Fr 35cc IAB kits in Japan are most at risk. Patients receiving these kits during procedures could be affected if endotoxins are present.

How to tell if you have this one

Check for the kit lot numbers listed: 3000079504 through 3000099589. The product is a YAMATO PLUS-R 7.5Fr 35cc IAB kit sold in Japan with specific part number 0684-00-0560-01.

Brand
Datascope
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Lot Number
Look for the lot numbers listed: 3000079504 through 3000099589 on the kit packaging.

✎ GovInfoNow

Questions people ask

What is the specific model of the recalled product?

The recalled product is the YAMATO PLUS-R 7.5Fr 35cc IAB kit with part number 0684-00-0560-01.

How can I tell if my kit is affected?

Check the kit lot number on the packaging; affected kits have lot numbers from 3000079504 to 3000099589.

What should I do if I have the recalled kit?

The recall record does not specify a remedy, so contact Datascope Corporation directly for further instructions.

Take action

Contact Datascope

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

✉️ Open in email

Subject: Recall Z-2846-2020 — Datascope Datascope

Hello,

I own a Datascope that is covered by recall Z-2846-2020 from Datascope.

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-2846-2020 (July 27, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2846-2020 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.

Datascope Corporation recalls Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product

Lower-risk recall