100 ft roll of tubing inside a cardboard box — Class III medical device recall Z-2325-2012
Terminated recall by Steris Corporation, reported 2012-09-12, distributed nationwide. On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected
| Recall number | Z-2325-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2012-08-02 |
| Classified | 2012-09-06 |
| Reported by FDA | 2012-09-12 |
| Terminated | 2013-09-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, PE |
| Quantity | 77 packages |
| Lot numbers | 60263 |
Product
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
Reason for recall
On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2325-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.