4 — Class II medical device recall Z-0526-2025
Ongoing recall by Karl Storz Endoscopy, reported 2024-12-04, distributed nationwide. Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
| Recall number | Z-0526-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Karl Storz Endoscopy, El Segundo, CA, United States |
| Recall initiated | 2024-10-11 |
| Classified | 2024-11-25 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE |
| Quantity | 105 devices |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04048551110751 |
| Lot numbers | 79745N, 80066N, 81369N, 81375N, 81806N, 82127N, 82133N, 82233N, 82968N, 82969N, 83219N, 83220N, 83233N, 83236N, 83245N, 83268N, 83460N, 83466N, 83468N, 83478N, 84074N, 84246N, 84247N, 84250N, 84265N, 84410N, 84416N, 84424N, 84440N, 84444N, 84447N, 84804N, 84808N, 84809N, 84813N, 84978N, 85013N, 85015N, 85184N, 85352N and 101 more |
| Model numbers | 20205FDS, 28205GDS, 28205HDS, 28205HES, 28205NDS, 28206CBS, 28208BKS, 28208IDS |
Product
4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x 4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x 5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x 5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x
Reason for recall
Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
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-0526-2025. 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.