Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

STERITITE Containers: STERITITE Container Kit Recalled by Advanced Sterilization Products Due to Advanced Sterilization Products (ASP) is recalling the SteriTite...

Date: October 3, 2013
Company: Advanced Sterilization Products
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Advanced Sterilization Products directly.

Affected Products

STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.

Quantity: 267 units total (252 units in US)

Why Was This Recalled?

Advanced Sterilization Products (ASP) is recalling the SteriTite containers because they do not have consistent data to show that sterility assurance level of 10(-6) is achieved during the half-cycle test runs on new, unprocessed containers.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Advanced Sterilization Products

Advanced Sterilization Products has 36 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report