Steris VERFIY Dual Specific Self-Contained Biological Indicators for Steam and ETO (S3060)

Brief description of the problem (reason for recall)

The manufacturer, STERIS, identified through testing that the Geobacillus stearothermophilus spore population fell below the minimum shelf-life specification. When the affected biological indicators are used to monitor steam sterilisation cycles, there is a potential risk that the indicator may show no growth, suggesting that the steam sterilisation cycle was effective, even though the spore population may have been inactivated before the intended spore reduction was achieved. This could result in an inaccurate interpretation of the effectiveness of the monitored steam sterilisation cycle.

Advice for health professionals and distributors:

Immediate Action Required

Please identify all affected stock currently held at your facility and immediately:

1. Remove the affected stock from use.
2. Place the affected stock in quarantine.
3. Clearly identify and segregate the affected stock from usable inventory.
4. Retain the affected stock in its original packaging.
5. Do not use, distribute, transfer or dispose of the affected stock until further instructions have been received from SafMed.

Once confirmation of the affected quantity and storage location has been received, SafMed will coordinate collection directly with your facility.

Please submit the completed information to dinagran@safmed.co.za by 14 September 2026 to assist us in completing the recall efficiently.

Please retain the affected stock in its current packaging and ensure that it remains clearly identified and segregated from usable stock until collection has been completed.

We apologise for any inconvenience this recall may cause and appreciate your immediate cooperation and assistance.

Should you require clarification regarding this recall, please contact Dinagran Padayachee on 011 201 4320 or email dinagran@safmed.co.za.

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points and the recall process was initiated.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.