Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR — Class II medical device recall Z-1450-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-04-10, distributed nationwide. Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The
| Recall number | Z-1450-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-02-23 |
| Classified | 2024-03-29 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 270 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00653160068252, 00653160068276, 00653160068283, 00653160288810, 00653160351293, 00653160351323, 10653160288817, 10653160351290, 10653160351320, 50653160068257, 50653160068271, 50653160068288 |
| Lot numbers | 2023031390, 2023032190, 2023061690, 2023110290, 2023110990, 2023112190, 2023112990 |
Product
Centurion Manual surgical kits labeled as: a) HEGAR UTERINE DILATOR, 11-12MM, STERILE, Product Code HUD112ST; b) STERILE UTERINE DILATOR 1MM/2MM, Product Code HUD12ST; c) HEGAR UTERINE DILATOR, 5-6MM, STERILE, Product Code HUD56ST; d) HEGAR UTERINE DILATOR, 9-10MM, STERILE, Product Code HUD910ST; e) HANK UTERINE DILATOR 11" 7/8FR STERILE, Product Code I68920; f) HANK UTERINE DILATOR 11" 13/14FR STERILE, Product Code I68930
Reason for recall
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
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-1450-2024. 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.