Use caution Medical device recall · FDA · Published April 11, 2025
Integra Craniotomy Kit Recall: Inadequate weld may cause disassembly
Integra LifeSciences recalls disposable cranial perforator kits with a potential weld issue that could cause disassembly. Affected models include specific lot numbers and UDI codes.
Use caution until it’s fixed
Inadequate weld that can potentially cause the product to disassemble.
Contact the company
Recalling firmIntegra LifeSciences Corp. (NeuroSciences)1100 Campus Rd · Princeton, NJ 08540-6650
What happened, in plain English
Integra NeuroSciences is recalling disposable craniotomy kits that may have inadequate welds, which could cause the product to disassemble. This poses a risk of injury during surgical procedures. Read more at govinfonow.com/recall/52460-integra-craniotomy-kit-recall-inadequate-weld-may-cause-disassembly.
Source Summary by GovInfoNow · govinfonow.com/recall/52460-integra-craniotomy-kit-recall-inadequate-weld-may-cause-disassembly · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1717-2025
Cite this page
“Integra Craniotomy Kit Recall: Inadequate weld may cause disassembly.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52460-integra-craniotomy-kit-recall-inadequate-weld-may-cause-disassembly. Based on FDA recall #Z-1717-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1717-2025%22&limit=1).
Why it’s dangerous
The kit has a weld that may not hold properly, potentially causing parts to separate during surgical procedures. This could lead to injury if the disassembly occurs while the device is in use.
Who’s affected
Surgical professionals using the recalled craniotomy kits are most at risk. Patients undergoing surgery with these kits could face complications if the product disassembles during use.
How to tell if you have this one
Check for model number 261230 and lot numbers listed in the recall notice. The unique device identifier (UDI) starts with 10381780513629.
- Brand
Integra NeuroSciences- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- 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.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1716-2025 | CODMAN Disposable Perforator, 14mm. Cranial perforator.; Model No. 261221; UDI 10381780513599; Lot No. Lot Number, 5580821, 5664307, 6347547, 6566289, 6589889, 6715286, 6715287, 6756578, 6756631, 6757665, 6899419, 6910166, 7008982, 7008995, 7009033, 7009035, 7009166, 7009167, 7092837, 7093002, 7124525, 7195332, 7195376, 7195380, 7230293, 7230295, 7230296, 7230430, 7230431, 7230437, 7230439, 7230440, 7230441, 7230442, 7230443, 7230444, 7230445, 7230446, 7230447, 7230448, 7230449, 7230450, 7230451, 7230452, 7230453, 7230454, 7230455, 7230456, 7230457, 7230458, 7230459, 7230460, 7230461, 7230462, 7230463, 7230464, 7230465, 7230466, 7230467, 7230468, 7230471, 7230472, 7230473, 7230474, 7230475, 7230476, 7230477, 7230478, 7230479, 7230480, 7230481, 7230482, 7230483, 7230484, 7230485, 7230486, 7230487, 7230488, 7230489, 7230490, 7230491, 7230492, 7230493, 7230494, 7230495, 7230496, 7230497, 7230498, 7230499, 7230500, 7230501, 7230502, 7230503, 7230504, 7230505, 7230506, 7230507, 7230508, 7230509, 7230510, 7230511, 7230512, 7230513, 7230514, 7230515, 7230516, 7230517, 7230518, 7230519, 7230523, 7230524, 7230525, 7230526, 7230527, 7230528, 7230529, 7230530, 7230531, 7230532, 7230533, 7230534, 7230535, 7230536, 7230537, 7230538, 7230539, 7230540, 7230541, 7230542, 7230543, 7230544, 7230545, 7230546, 7230547, 7230548, 7230549, 7230550, 7230551, 7230552, 7230553, 7230554, 7230555, 7230556, 7230557, 7230558, 7230559, 7230560, 7230561, 7230562, 7230563, 7230564, 7230565, 7230566, 7230567, 7230568, 7230569, 7230570, 7230571, 7230572, 7230573, 7230574, 7230575, 7230576, 7230577, 7230578, 7230579, 7230580, 7230581, 7230582, 7230583, 7230584, 7230585, 7230586, 7230587, 7230588, 7230589, 7230590, 7230591, 7230592, 7230593, 7230594, 7230595, 7230596, 7230597, 7230598, 7230599, 7230600, 7230601, 7230602, 7230603, 7230604, 7230605, 7230606, 7230607, 7230608, 7230609, 7230610, 7230611, 7230612, 7230613, 7230614, 7230615, 7230616, 7230617, 7230618, 7230619, 7230620, 7230621, 7230622, 7230623, 7233015, 7233016, 7233017, 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7373208, 7373209, 7373210, 7373211, 7373212, 7373213, 7373214, 7373215, 7373216, 7373217, 7373218, 7373219, 7373220, 7373221, 7373222, 7373223, 7373224, 7373225, 7373226, 7373227, 7373228, 7373229, 7373230, 7373231, 7373232, 7373233, 7373234, 7373235, 7373236, 7373237, 7373238, 7373239, 7373240, 7373241, 7373242, 7388855, 7388856, 7388857, 7388858, 7388859, 7388860, 7388861, 7388863, 7388864, 7388865, 7388866, 7388867, 7388868, 7388869, 7388870, 7388871, 7388872, 7388873, 7388874, 7388875, 7388876, 7388877, 7388878, 7388879, 7388880, 7388881, 7388882, 7388883, 7388884, 7388885, 7388886, 7388887, 7388888, 7388890, 7388891, 7388892, 7388893, 7388894, 7388895, 7388896, 7388897, 7388898, 7388899, 7388900, 7388901, 7388902, 7388903, 7388904, 7388905, 7388906, 7388907, 7388908, 7388909, 7388910, 7388911, 7388912, 7388913, 7388914, 7388915, 7388916, 7388917, 7388918, 7388919, 7388920, 7388921, 7388922, 7388923, 7388924, 7388925, 7388926, 7388927, 7388928, 7388929, 7388931, 7388932, 7388933, 7388934, 7388935, 7388936, 7388937, 7388938, 7388939, 7388940, 7388941, 7388943, 7388944, 7388945, 7388946, 7388947, 7388948, 7388949, 7388950, 7388951, 7388952, 7388953, 7388954, 7388955, 7388956, 7388957, 7388958, 7388959, 7388960, 7388961, 7388962, 7388963, 7388964, 7388965, 7388966, 7388967, 7388968, 7388969, 7388970, 7388971, 7388972, 7388973, 7388974, 7388975, 7388976, 7388977, 7388978, 7388979, 7388980, 7388981, 7388982, 7388983, 7388984, 7388985, 7388986, 7388987, 7388988, 7388989, 7388990, 7388991, 7388992, 7388993, 7388994, 7388995, 7388996, 7388997, 7388998, 7388999, 7389000, 7389001, 7389002, 7389003, 7389004, 7389005, 7389006, 7389007, 7389008, 7389009, 7389010, 7389011, 7389012, 7389013, 7389014, 7389015, 7389016, 7389017, 7389018, 7389019, 7389020, 7389021, 7389022, 7389023, 7389024, 7389025, 7389026, 7389027, 7389028, 7389029, 7389030, 7389031, 7389032, 7389033, 7389034, 7389035, 7389036, 7389037, 7389038, 7389039, 7389040, 7389041, 7389042, 7389043, 7389044, 7389045, 7389046, 7389047, 7389048, 7389049, 7389050, 7389051, 7389052, 7389053, 7389054, 7389055, 7389056, 7389057, 7389058, 7389059, 7389060, 7389061, 7389062, 7389063, 7389064, 7389065, 7389066, 7389067, 7389068, 7389069, 7389070, 7389071, 7389072, 7389073, 7389074, 7389075, 7389076, 7389077, 7389078, 7389079, 7389080, 7389081, 7389082, 7389083, 7389084, 7389085, 7389086, 7389087, 7389088, 7389089, 7389090, 7389091, 7389092, 7389093, 7389094, 7389095, 7389096, 7389097, 7389098, 7389099, 7389100, 7389101, 7389102, 7400936, 7400937, 7400938, 7400939, 7400940, 7400941, 7400942, 7400943, 7400944, 7400945, 7400946, 7400947, 7400948, 7400949. | 170,510 units |
| Z-1717-2025 | CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.; Model No. 261230; UDI: 10381780513629; Lot No. Lot Number, 5984530, 7062002, 7062006, 7062013, 7062014, 7255930, 7255931, 7255932, 7255933, 7255934, 7255935, 7255936, 7255937, 7269522, 7269523, 7269524, 7269525, 7282944, 7282945, 7282946, 7282948, 7282949, 7282950, 7282951, 7282952, 7282953, 7293408, 7293409, 7293410, 7293411, 7293412, 7293413, 7293414, 7322892, 7322893, 7322894, 7322895, 7322896, 7322897, 7322898, 7332664, 7332665, 7332666, 7332667, 7332668, 7348744, 7348745, 7348746, 7348747, 7348748, 7371080, 7371081, 7379573, 7379576, 7379577, 7379578. | 1,840 units |
What to do — step by step
Check Product Details
Verify the model number (261230) and lot numbers from the recall list to confirm if your kit is affected.
Contact Manufacturer
Reach out to Integra NeuroSciences for guidance on next steps if your kit is confirmed affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 33 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall indicates a potential weld issue that could cause disassembly, so it is not safe to use without confirmation of the fix.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1717-2025 (April 11, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1717-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.