Cordis — Class II medical device recall Z-0740-2013
Terminated recall by Cordis Corporation, reported 2013-02-06, distributed nationwide. Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterili
| Recall number | Z-0740-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2012-10-29 |
| Classified | 2013-01-25 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2013-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 98,675 units |
| Reason classes | sterility |
| Lot numbers | 15408606, 15409332, 15410622, 15410623, 15410906, 15411659, 15424968, 15426890, 15429098, 15429879, 15430798, 15433095, 15433098, 15437509, 15437958, 15441594, 15443327, 15444208, 15446063, 15448005, 15449422, 15451542, 15452987, 15453540, 15455770, 15455771, 15456567, 15456568, 15459366, 15459367, 15461179, 15461781, 15462779, 15462780, 15463296, 15463297, 15464298, 15464299, 15466361, 15466362 and 90 more |
| Model numbers | EX500, EX600, EX700 |
Product
Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.
Reason for recall
Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product. Model Numbers EX500, EX600, and EX700.
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-0740-2013. 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.