Dilator — Class II medical device recall Z-1532-2024

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-1532-2024`
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	4,856 units
Reason classes	potency, sterility, packaging
UPC / GTIN / UDI-DI	`00827002039278`, `00827002039285`, `00827002039292`, `00827002039322`, `00827002039476`, `00827002040519`, `00827002042216`, `00827002042643`, `00827002044432`
Model numbers	`JCD10.0-38-20`

Product

Dilator - Coons Taper - 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- COONS G03928 2) JCD12.0-38-20- COONS G03929 3) JCD14.0-38-20- COONS G03932 4) JCD16.0-38-20- COONS G03947 5) JCD18.0-38-20- COONS G04051 6) JCD20.0-38-20- COONS G04264 7) JCD22.0-38-20- COONS G04443 8) JCD6.0-38-20- COONS G04221 9) JCD8.0-38-20- COONS G03927

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-1532-2024. 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.