FDA Device recall Z-1180-2013
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard met…
- FDA Device
- Class II
- terminated
- Published 2013-05-08
On 2013-05-08 the FDA classified a Class II recall of STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard met… by Advanced Sterilization Products, citing advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1180-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-22 |
| Published | 2013-05-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Advanced Sterilization Products |
| Distribution | US |
Product
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Reason
Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicator product because it may not have adequate data to support the entire duration of the labeled shelf-life.
Identifiers
| code_info | Lot Codes: 025127 026127 027127 028127 030127 031127 032127 033127 034127 035127 036127 037127 038121 0…Lot Codes: 025127 026127 027127 028127 030127 031127 032127 033127 034127 035127 036127 037127 038121 038127 039127 040127 041121 042127 043127 044127 045121 046127 047127 048127 049127 052127 053121 053127 054127 055121 056127 057127 058127 059127 060127 061127 062121 062127 063127 064127 065127 067127 068127 069121 070127 071127 072127 073127 076121 081127 082127 084127 085127 086121 086127 087127 089127 090127 091127 092127 093121 094127 095127 100121 100127 101127 102127 104127 107121 107127 107128 109127 109128 110127 111127 114121 118127 121121 121127 122127 123127 124127 125127 128121 128127 129127 130127 131127 132127 135121 135127 136127 137127 156121 156127 158127 159127 160127 163121 163127 164127 165127 13912706 18112706 18412706 18512706 18712706 18812706 19012706 19212706 19312706 19412706 19512706 19712706 19812106 19912706 20012106 20112706 20212706 |
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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-1180-2013%22
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