Integra LifeSciences Corp. (NeuroSciences) — CODMAN Disposable Perforator 11mm. Cranial Perforator.
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 26, 2025
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Ecuador, France, French Guiana, Germany, Greece, India, Ireland, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Morrocco, Netherlands, New Zealand, Palestine, State of, Philippines, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan , Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam.
What's affected?
- Product
- CODMAN Disposable Perforator 11mm. Cranial Perforator.
- Lot code
- No
Additional details
Model No. 261222; UDI: 10381780513612; Lot No. 7221964, 7221972, 7221976, 7221977, 7221978, 7221979, 7221980, 7221981, 7221982, 7221983, 7221984, 7221985, 7221986, 7221987, 7221988, 7221989, 7221990, 7221991, 7230624, 7230625, 7230626, 7230627, 7230628, 7230629, 7230630, 7230631, 7230632, 7230633, 7230634, 7230635, 7230636, 7230637, 7230638, 7230639, 7230640, 7230641, 7230642, 7230643, 7230644, 7230645, 7230646, 7230647, 7230648, 7230649, 7230650, 7230651, 7230652, 7230653, 7230654, 7230655, 7230656, 7230657, 7230658, 7230659, 7230660, 7230661, 7282989, 7282990, 7282991, 7282992, 7282993, 7282994, 7282995, 7282996, 7282997, 7282998, 7282999, 7283000, 7283001, 7283002, 7283003, 7283004, 7283005, 7283006, 7283007, 7293432, 7293433, 7293434, 7293435, 7293436, 7293437, 7293438, 7293439, 7293440, 7293441, 7293442, 7293443, 7293444, 7293445, 7293446, 7293447, 7293448, 7293450, 7308709, 7308710, 7293449, 7293451, 7308706, 7308707, 7308708, 7308711, 7308712, 7308713, 7308714, 7308715, 7322887, 7322888, 7322889, 7322890, 7322891, 7323305, 7323306, 7323307, 7323308, 7323309, 7332669, 7332670, 7332671, 7332672, 7332673, 7332674, 7332675, 7332676, 7332677, 7348757, 7348758, 7348759, 7348760, 7348761, 7348762, 7348763, 7348764, 7348765, 7348766, 7348767, 7348768, 7348769, 7348770, 7348771, 7348772, 7348773, 7348774, 7348775, 7348776, 7348777, 7348778, 7348779, 7348780, 7348781, 7348782, 7371090, 7371091, 7371092, 7371093, 7371094, 7371095, 7371096, 7371097, 7371098, 7371099, 7371100, 7371101, 7371102, 7371103, 7387974, 7387975, 7387976, 7387977, 7387978, 7387979, 7387980, 7387981, 7387982, 7387983, 7387984, 7387985, 7387986, 7387987, 7387991, 7402327, 7402328, 7402329, 7402330, 7402331, 7402332, 7402333, 7402334, 7406854, 7406855, 7406856, 7406857, 7406858, 7406859, 7406860, 7406861, 7448431, 7448432, 7448433, 7448434; Expiration Date: 2028-04-30 to 2029-07-31.
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 16,251 units.
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