IBC Aortic Punch Catalog Numbers APM40 — Class II medical device recall Z-2423-2015
Terminated recall by International Biophysics Corp., reported 2015-08-26, distributed nationwide. It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
| Recall number | Z-2423-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | International Biophysics Corp., Austin, TX, United States |
| Recall initiated | 2015-08-07 |
| Classified | 2015-08-19 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2016-03-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, DE, NO, PK, TR, ZA |
| Quantity | 10,330 units |
| Reason classes | potency, sterility, packaging |
| Model numbers | APL40A, APL44, APL48A, APM28, APM28BM, APM36, APM36BK, APM36BM, APM40, APM40A, APM40BK, APM40BM, APM44A, APM44BK, APM44BM, APM48BK, APM48BM, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52 |
Product
IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.
Reason for recall
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
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-2423-2015. 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.