MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY — Class II medical device recall Z-1364-2026
Ongoing recall by Integra LifeSciences Corp. (NeuroSciences), reported 2026-02-25, distributed nationwide. Potential packaging failures, which could lead to a breach in the sterile barrier.
| Recall number | Z-1364-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ, United States |
| Recall initiated | 2026-01-16 |
| Classified | 2026-02-13 |
| Reported by FDA | 2026-02-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BH, CA, CH, DE, ES, FI, FR, GB, GR, HU, IE, IL, IQ, IR, IT, KR, KW, LB, MY, NL, NO, NZ, PL, PT, RO, RS, SA, SI, TN |
| Quantity | 55,276 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10381780486909, 10381780486916, 10381780486923 |
| Lot numbers | A21056, A22036, A22047, A23045, A23065, A24008, A24036, A24057, A25028, A25056, B21062, B21084, B21100, B21107, B21119, B21123, B23079, B24075, B25068, B25077, B25110, C21151, C21152, C21155, C21195, C22159, C22182, C22196, C23177, C23183, C23193, C24148, C25152, D21229, D21247, D22251, D22270, D22275, D23196, D23208 and 87 more |
| Model numbers | 31012, 31022, 31045 |
Product
MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds
Reason for recall
Potential packaging failures, which could lead to a breach in the sterile barrier.
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-1364-2026. 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.