CODMAN 9mm Disposable Perforator (Integra) – weld inadequacy (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CODMAN Disposable Perforator 9mm. Cranial Perforator.
Brand
Integra LifeSciences Corp. (NeuroSciences)
Lot Codes / Batch Numbers
Model No. 261223, UDI: 10381780513605, Lot No. 5828553, 6264478, 6264481, 6264482, 7230672, 7230673, 7230674, 7230675, 7261971, 7268008, 7268009, 7268010, 7268011, 7268012, 7268013, 7268014, 7268015, 7268016, 7268017, 7268018, 7268019, 7282954, 7282955, 7293422, 7293423, 7293424, 7293425, 7293426, 7293427, 7293428, 7300667, 7300668, 7300669, 7300670, 7300672, 7300673, 7300674, 7371082, 7371083, 7379652, 7379922, 7379923, 7379924, 7379926, 7379928, 7379660, 7379925, 7379927, 7450559, 7450560, 7450561, 7450562, 7450563, 7450564, 7450565, 7450566, 7451273, 7451274, 7451275, 7451276, 7451277, 7451278, 7451279, Expiration Date: 2024-03-31 to 2029-07-31.
Products Sold
Model No. 261223; UDI: 10381780513605; Lot No. 5828553, 6264478, 6264481, 6264482, 7230672, 7230673, 7230674, 7230675, 7261971, 7268008, 7268009, 7268010, 7268011, 7268012, 7268013, 7268014, 7268015, 7268016, 7268017, 7268018, 7268019, 7282954, 7282955, 7293422, 7293423, 7293424, 7293425, 7293426, 7293427, 7293428, 7300667, 7300668, 7300669, 7300670, 7300672, 7300673, 7300674, 7371082, 7371083, 7379652, 7379922, 7379923, 7379924, 7379926, 7379928, 7379660, 7379925, 7379927, 7450559, 7450560, 7450561, 7450562, 7450563, 7450564, 7450565, 7450566, 7451273, 7451274, 7451275, 7451276, 7451277, 7451278, 7451279; Expiration Date: 2024-03-31 to 2029-07-31.
Integra LifeSciences Corp. (NeuroSciences) is recalling CODMAN Disposable Perforator 9mm. Cranial Perforator. due to Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an ab. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Recommended Action
Per FDA guidance
An URGENT: MEDICAL DEVICE RECALL notification dated 9/26/25 was mailed to consignees. Customers with affected devices are to be immediately removed and quarantined. Customers are to send their completed Acknowledgement Form to FCA3@integralife.com or by fax at 1-609-750-4220. Forward the recall notification to those who use the product for their awareness. Integra Customer Service will reach out to consignees to facilitate product return. Distributors and Sales Representatives with affected devices are to remove product from further distribution. They are to send their completed Acknowledgement Form to FCA3@integralife.com or by fax at 1-609-750-4220. Distributors are to create an acknowledgement form from the distributor to their customers and provide them with a copy of the recall notification. Sales Representatives are to receive further directions from Integra Customer Service after their Acknowledgement Form has been received. Consignees with any questions are to call 1-800-654-2873 or email custsvcnj@integralife.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026