Reported Jan 22, 2025 · Ongoing

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number…

Sklar Instruments

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: Sklar Instruments · 1333 Lenape Rd · West Chester, PA · 19382-6816

Is this the product you have?

  • ECONO STERILE
  • medical procedure kits labeled as1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy
Lot codes and dates
    • 1) 96-4134M
    • UDI/DI 50649111492547
  • Lot codes
    • SK-114
    • 2) 96-4137M
    • UDI/DI 50649111492530
  • Lot codesSK-116
Amount recalled
0 units

This recall covers 30 products

The agency filed one notice per product. You are reading one of them; the other 29 are below.

17 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Reports of various packaging issues that may result in a breach of the sterile barrier.

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

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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, 7:13 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.