Reported Mar 26, 2025 · Ongoing

C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04

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?

  • C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
Lot codes and dates
  • UDI-DI 00191072219596 Lots 907241 70-050816 70-051301 70-051839 70-052420 70-052910 70-053100
Amount recalled
1106 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.