Reported Mar 26, 2025 · Ongoing

LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02

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 · 85 Shaffer Park Dr · Tiffin, OH · 44883-9290

Is this the product you have?

  • LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
Lot codes and dates
  • UDI-DI 00191072219206 Lots 882241 70-051163 70-051373 70-051564 70-052582 70-053048
Amount recalled
630 kits

This recall covers 33 products

The agency filed one notice per product. You are reading one of them; the other 32 are below.

20 more are in the archive.

Where it was sold

  • Nationwide
  • OH

Why it was recalled

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

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, 4:17 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.