Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported May 14, 2025
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Inadequate weld that can potentially cause the product to disassemble.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Integra LifeSciences Corp. (NeuroSciences) recalled CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial … - a critical-severity action.
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial … was recalled by Integra LifeSciences Corp. (NeuroSciences) in May 14, 2025. Reason: Inadequate weld that can potentially cause the product to disassemble.. Check the official notice for the remedy. Verify recall #Z-1717-2025 with the FDA Devices before acting.
The recall
Integra LifeSciences Corp. (NeuroSciences) issued this critical-severity FDA Devices recall-Inadequate weld that can potentially cause the product to disassemble..
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- May 14, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1717-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1717-2025) was formally reported on May 14, 2025, with the manufacturer initiating the action on April 11, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Integra LifeSciences Corp. (NeuroSciences) is listed as the recalling firm, operating out of Princeton, NJ. Federal records list the affected scope as 1,840 units.
The documented reason for this recall is: Inadequate weld that can potentially cause the product to disassemble. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican Republic, Ecuador…. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,840 units
Related Recalls
6
3 from same agency
Product description
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Reason for recall
Inadequate weld that can potentially cause the product to disassemble.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1717-2025 |
| Date reported | May 14, 2025 |
| Date initiated | April 11, 2025 |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences) |
| Firm location | Princeton, NJ |
| Affected scope | 1,840 units |
| Distribution | Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican Republic, Ecuador, El Salvador, Franc… |
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-1717-2025) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.. Recalled by Integra LifeSciences Corp. (NeuroSciences). Units affected: 1,840 units.
Why was this product recalled? ▼
Inadequate weld that can potentially cause the product to disassemble.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 14, 2025. Severity: Critical. Recall number: Z-1717-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican Republic, Ecuador, El Salvador, France, French Guiana, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (the Republic of), Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1717-2025) 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 May 14, 2025. 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.