Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 26, 2015
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.
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
International Biophysics Corp. recalled IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40,… - a moderate-severity action.
IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40,… was recalled by International Biophysics Corp. in August 26, 2015. Reason: It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.. Check the official notice for the remedy. Verify recall #Z-2423-2015 with the FDA Devices before acting.
The recall
International Biophysics Corp. issued this moderate-severity FDA Devices recall-It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria..
- Moderate
- severity level
- 10K units
- affected scope
- Class II
- classification
- August 26, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2423-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2423-2015) was formally reported on August 26, 2015, with the manufacturer initiating the action on August 7, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. International Biophysics Corp. is listed as the recalling firm, operating out of Austin, TX. Federal records list the affected scope as 10,330 units.
The documented reason for this recall is: It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. Distribution data in the federal record shows the product reached: Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
10,330 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2423-2015 |
| Date reported | August 26, 2015 |
| Date initiated | August 7, 2015 |
| Recalling firm | International Biophysics Corp. |
| Firm location | Austin, TX |
| Affected scope | 10,330 units |
| Distribution | Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2423-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by International Biophysics Corp.. Units affected: 10,330 units.
Why was this product recalled? ▼
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 26, 2015. Severity: Moderate. Recall number: Z-2423-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2423-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 26, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.