FDA Device recall Z-1822-2013

Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Me…

FDA Device
Class II
terminated
Published 2013-08-07

On 2013-08-07 the FDA classified a Class II recall of Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 EZTest Steam Biological Indicator: Me… by Steritec Products Mfc, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1822-2013
Classification	Class II
Status	terminated
Initiated	2013-06-10
Published	2013-08-07
Last updated	2026-09-13 11:53 UTC
Company	Steritec Products Mfc
Distribution	US

Product

Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 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.

Reason

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.

Identifiers

code_info	Affected Biological Indicator Lot No.: S-444

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1822-2013%22

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