Reported Apr 2, 2025 · Ongoing

Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description:…

American Contract Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: American Contract Systems, Inc. · 7300 W Detroit St · Chandler, AZ · 85226-2410

Is this the product you have?

  • Brand NameBanner
  • Health Systems Product NameCysto
  • Pack Model/Catalog NumberBHCY31E
  • Product DescriptionConvenience
  • Kit ComponentNo
Lot codes and dates
  • Lot CodeUDI-DI: 00191072234261
  • Lot9221789
  • Exp01/21/2026
Amount recalled
800

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

Sterility assurance with procedure trays

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.