Steris Verify Dual Specific Self-Contained Biological Indicators for Steam and ETO (S3060) are being recalled in South Africa by SafMed (Pty) Ltd, 11 Mercury Crescent, Hillstar Industrial, Wetton, Cape Town. The recall is classified Class II Type C and dated 7 September 2026.
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 the 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.
| Lot | Expiry |
|---|---|
| 260810 | 10 August 2026 |
| 261106 | 6 November 2026 |
| 270116 | 16 January 2027 |
| 270302 | 2 March 2027 |
Pack sizes are 50 and 100. First distribution dates are 13 January 2026 and 14 August 2026. No registration number is listed.
Health professionals and distributors are instructed to identify all affected stock held at their facility and immediately remove it from use, place it in quarantine, clearly identify and segregate it from usable inventory, and retain it in its original packaging. Affected stock must not be used, distributed, transferred or disposed of until further instructions are received from SafMed.
Facilities are asked to submit confirmation of affected quantity and storage location to dinagran@safmed.co.za by 14 September 2026, after which SafMed will coordinate collection directly. Queries go to Dinagran Padayachee on 011 201 4320 or the same email address.
Source: SAHPRA — https://www.sahpra.org.za/document/steris-verfiy-dual-specific-self-contained-biological-indicators-for-steam-and-eto-s3060/
