CD5 Series of Genesis Reusable Rigid Sterilization Container Systems… — Class II medical device recall Z-1236-2023
Ongoing recall by Carefusion 2200 Inc, reported 2023-03-15, distributed nationwide. Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis con
| Recall number | Z-1236-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 2200 Inc, Vernon Hills, IL, United States |
| Recall initiated | 2023-01-30 |
| Classified | 2023-03-09 |
| Reported by FDA | 2023-03-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, DK, ES, FI, GB, HK, IE, JP, KR, MY, PH, PL, SA, SE, SG, TH, TW |
| Quantity | 5,952 devices |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10885403019548, 10885403019555, 10885403019579, 10885403019586, 10885403196461, 10885403196478, 10885403196485, 10885403196492, 10885403196515, 10885403196522, 10885403196539, 10885403196546, 10885403196553, 10885403196560, 10885403196577, 10885403197925, 10885403197932, 10885403197949, 10885403197956, 10885403197963, 10885403197970, 10885403197987, 10885403197994, 10885403198007, 10885403198014 and 3 more |
Product
CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS CONT LARGE ENDO SOLID 28X11X6IN; 5. CD5-3B-BLACK, GENESIS LG NARROW 3" PERF BOTTOM BLACK; 6. CD5-3B-BLUE, GENESIS LG NARROW 3" PERF BOTTOM BLUE; 7. CD5-3B-GOLD, GENESIS LG NARROW 3" PERF BOTTOM GOLD; 8. CD5-3B-GREEN, GENESIS LG NARROW 3" PERF BOTTOM GREEN; 9. CD5-3B-PURPLE, GENESIS LG NARROW 3" PERF BOTTOM PURPLE; 10. CD5-3B-RED, GENESIS LG NARROW 3" PERF BOTTOM RED; 11. CD5-3C-BLACK, GENESIS LG NARROW 3" SOLID BOTTOM BLACK; 12. CD5-3C-BLUE, GENESIS LG NARROW 3" SOLID BOTTOM BLUE; 13. CD5-3C-GOLD, GENESIS LG NARROW 3" SOLID BOTTOM GOLD; 14. CD5-3C-GREEN, GENESIS LG NARROW 3" SOLID BOTTOM GREEN; 15. CD5-3C-PURPLE, GENESIS LG NARROW 3" SOLID BOTTOM PURPLE; 16. CD5-3C-RED, GENESIS LG NARROW 3" SOLID BOTTOM RED; 17. CD5-61B-BLACK, GENESIS LG NARROW 6" PERF BOTTOM BLACK; 18. CD5-61B-BLUE, GENESIS LG NARROW 6" PERF BOTTOM BLUE; 19. CD5-61B-GOLD, GENESIS LG NARROW 6" PERF BOTTOM GOLD; 20. CD5-61B-GREEN, GENESIS LG NARROW 6" PERF BOTTOM GREEN; 21. CD5-61B-PURPLE, GENESIS LG NARROW 6" PERF BOTTOM PURPLE; 22. CD5-61B-RED, GENESIS LG NARROW 6" PERF BOTTOM RED; 23. CD5-61C-BLACK, GENESIS LG NARROW 6" SOLID BOTTOM BLACK 24. CD5-61C-BLUE, GENESIS LG NARROW 6" SOLID BOTTOM BLUE; 25. CD5-61C-GOLD, GENESIS LG NARROW 6" SOLID BOTTOM GOLD; 26. CD5-61C-GREEN, GENESIS LG NARROW 6" SOLID BOTTOM GREEN; 27. CD5-61C-PURPLE, GENESIS LG NARROW 6" SOLID BOTTOM PURPLE; 28. CD5-61C-RED, GENESIS LG NARROW 6" SOLID BOTTOM RED.
Reason for recall
Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.
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-1236-2023. 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.