CLASS II Device recall · Reported 7 Aug 2013 · FDA Enforcement Report
Cardinal Steam Biological Indicator, SteriTec Product recalled
Steritec Products Mfc. Co is recalling Cardinal Steam Biological Indicator, SteriTec Product, distributed nationwide in the US. The recall was initiated on 10 Jun 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1823-2013
- FDA event ID
- 65473
- Recalling firm
- Steritec Products Mfc. Co, Englewood, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2013
- FDA classified
- 29 Jul 2013
- Reported
- 7 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Patient Monitors
Timeline
| 10 Jun 2013 | Recall initiated by company | |
| 29 Jul 2013 | Classified by FDA | +49 days |
| 7 Aug 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam sterilization cycles. Mesa EZTest has a recommended incubation time of 24 hours.
Where it was distributed
Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
Questions about this recall
Is Cardinal Steam Biological Indicator, SteriTec Product recalled?
Yes. Steritec Products Mfc. Co recalled Cardinal Steam Biological Indicator, SteriTec Product on 10 Jun 2013. The recall is Class II and its status is Terminated. Recall number Z-1823-2013.
Why was it recalled?
Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.
Which lots are affected?
Affected Biological Indicator Lot No.: S-444
Where was it sold?
Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Steritec Products Mfc. Co
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product recalled | Steritec Products Mfc. Co | Sterility | Nationwide |
| Device | CLASS II | Medline Med-Checks BI Test packs recalled by Steritec Products Mfc. Co | Steritec Products Mfc. Co | Sterility | Nationwide |
| Device | CLASS II | EZTest Steam Biological Indicator, SteriTec Product recalled | Steritec Products Mfc. Co | Sterility | Nationwide |
| Device | CLASS II | Cardinal BI Stat Biological Test Pack recalled | Steritec Products Mfc. Co | Sterility | Nationwide |
| Device | CLASS II | Getinge Assure Accufast BI Test Pack w/ 25 Controls recalled | Steritec Products Mfc. Co | Sterility | Nationwide |
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| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
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