Dilator With AQ Hydrophilic Coating — Class II medical device recall Z-1531-2024
Ongoing recall by Cook Incorporated, reported 2024-04-24, distributed nationwide. Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
| Recall number | Z-1531-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2024-03-01 |
| Classified | 2024-04-12 |
| Reported by FDA | 2024-04-24 |
| Distributed | Nationwide (US) |
| Quantity | 1,493 units |
| Reason classes | potency, sterility, packaging |
| UPC / GTIN / UDI-DI | 00827002102064, 00827002102071, 00827002102859, 00827002102897, 00827002102934 |
| Model numbers | G10206, G10207, G10285, G10289, G10293, JCD10.0-38-20-HC, JCD14.0-38-20-HC, JCD16.0-38-20-HC, JCD6.0-38-20-HC, JCD8.0-38-20-HC |
Product
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20-HC G10207 2) JCD14.0-38-20-HC G10293 3) JCD16.0-38-20-HC G10206 4) JCD6.0-38-20-HC G10285 5) JCD8.0-38-20-HC G10289
Reason for recall
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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-1531-2024. 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.