Home / Recalls / Integra LifeSciences Corp. (NeuroSciences) / Z-0373-2026

Z-0373-2026 Class I Ongoing

Recalled by Integra LifeSciences Corp. (NeuroSciences) — Princeton, NJ

FDA device recall Z-0373-2026 was initiated by Integra LifeSciences Corp. (NeuroSciences) on September 26, 2025 and is designated Class I. Reason for recall: 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. The recall status is ongoing. Affected quantity: 16,251 units.

Recall Details

Product Type
Devices
Report Date
November 12, 2025
Initiation Date
September 26, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,251 units

Product Description

CODMAN Disposable Perforator 11mm. Cranial Perforator.

Reason for Recall

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.

Distribution Pattern

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.

Code Information

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.

Other recalls by Integra LifeSciences Corp. (NeuroSciences)

  • Z-2714-2026 Class II — OmniTract Surgical Retractor System, which includes 633 of the firm s product co (June 5, 2026)
  • Z-2173-2026 Class II — Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product (April 10, 2026)
  • Z-1819-2026 Class II — Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. (March 19, 2026)
  • Z-1818-2026 Class II — Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. (March 19, 2026)
  • Z-1820-2026 Class II — Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. (March 19, 2026)
  • Z-1817-2026 Class II — Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. (March 19, 2026)
  • Z-1816-2026 Class II — Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. (March 19, 2026)
  • Z-1828-2026 Class II — CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical asp (March 6, 2026)
  • Z-1363-2026 Class II — MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (January 16, 2026)
  • Z-1364-2026 Class II — MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31 (January 16, 2026)

FDA data resources