FDA Medical devices recall ·
CODMAN Disposable Perforator 11mm recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0373-2026
- Date
- (initiated September 26, 2025)
- Company / brand
- Integra LifeSciences Corp. (NeuroSciences)
1100 Campus Rd, Princeton, NJ, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 16,251 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CODMAN Disposable Perforator 11mm. Cranial Perforator.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, 7371
Distribution
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.
States: Puerto Rico
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0373-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.