Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ProSpore 4 mL Ampoule Biological indicator for steam sterilization Recalled by Mesa Laboratories Inc Due to Product resistance has fallen outside of label claim...

Date: April 4, 2016
Company: Mesa Laboratories Inc
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 Mesa Laboratories Inc directly.

Affected Products

ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.

Quantity: 328/ 50-count/ boxes; 16,400 individual units

Why Was This Recalled?

Product resistance has fallen outside of label claim within expiry.

Where Was This Sold?

This product was distributed to 11 states: AL, AR, CA, FL, IA, MO, NE, NY, NC, OH, WA

Affected (11 states)Not affected

About Mesa Laboratories Inc

Mesa Laboratories Inc has 1 total recall tracked by RecallDetector.

Related Recalls

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