Device recall: VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in…
Class II FDA enforcement event 91315. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if…
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Steris Corporation started this device recall on 12 Dec 2022. The firm address in the FDA record is in Mentor, OH. FDA put the recall in Class II. FDA event 91315 has 4 product records. The first FDA enforcement report date is 11 Jan 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
Recalling firm
Steris Corporation, Mentor, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0778-2023 | VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes | 338 boxes | Class II | Ongoing | 11 Jan 2023 |
| Z-0779-2023 | VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes | 857 boxes | Class II | Ongoing | 11 Jan 2023 |
| Z-0780-2023 | VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes | 60 boxes | Class II | Ongoing | 11 Jan 2023 |
| Z-0781-2023 | VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes | 105 boxes | Class II | Ongoing | 11 Jan 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 4Median of the firm: 1
- Events of the firm on the register
- 58
Other events of the firm
Official channels
- FDA enforcement report Z-0778-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 91315. https://recallregister.com/fda/ii/91315/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
- What quantity of product is in FDA event 91315?
- The event has 4 product records. The first record gives this quantity:
338 boxes
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.