Integra LifeSciences recalls Codman Cranial Access Kits with incorrect expiration dates on outer box labels. Using past expiration date may cause pain, infection, or adverse tissue reactions. Affected kits have specific part and lot numbers.
Incorrect extended expiration dates identified on the outer box label only, if product is used past the correct expiration date there is a potential for pain, infection, or adverse tissue reaction to occur
“Codman Cranial Access Kits: Incorrect Expiration Dates Risk Pain or Infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61229-codman-cranial-access-kits-incorrect-expiration-dates-risk-pain-or. Based on FDA recall #Z-0818-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0818-2022%22&limit=1).
Integra LifeSciences Corp. recalled Codman Cranial Access Kits on Jan. 21, 2022, after the FDA announced incorrect expiration dates on outer boxes could cause pain or infection if used past the correct date. The firm initiated this voluntary Class II recall affecting 1,160 kits distributed worldwide.
How to tell if you have it
Brand: Integra LifeSciences
Product: Codman Cranial Access Kits
Part Number: 826616
Lot Numbers: 20DDA264, 21HDA861
UDI#: 10381780520382
The hazard
The recall involves incorrect extended expiration dates identified on the outer box label only. According to the FDA, if the product is used past the correct expiration date, there is a potential for pain, infection, or adverse tissue reaction to occur.
Context
GovInfoNow's records show Integra LifeSciences Corp. has 35 other recalls on record since Aug. 18, 2017. Recent brand recalls include the Feb. 6, 2025 AURORA Surgiscope System Recall for a risk of obturator breaking and the Jan. 10, 2025 MediHoney Wound Dressing Gel Recall regarding induction seal packaging risks. Other recent recalls of similar products include the May 13, 2026 Medtronic 1x4 Pocket Adaptor Kit for incorrect use-by-dates and the Dec. 29, 2025 Cerapedics PearMatrix P-15 Bone Graft Recall for an incorrect expiration date.
How to tell if you have this one
Check the outer box label for expiration dates. Affected kits have part number 826616 and lot numbers 20DDA264 or 21HDA861.
Brand
Integra LifeSciences
Category
Medical device
FDA recall event · 2 products
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 II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide and the country of Hong Kong.
Recall number
Product, codes & lots
Quantity
Z-0817-2022
Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Product umber: 826614; Lot Numbers: 20LDC222, 21HDC461 UDI# 10381780520375
1161 kits
Z-0818-2022
Codman Cranial Access Kits- indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage procedures. Part Number: 826616; Lot Numbers: 20DDA264, 21HDA861 UDI# 10381780520382
1160 kits
Based on the official FDA remedy
What to do — step by step
Check Expiration Date
Verify the expiration date on the outer box label. If it's past the correct expiration date, stop using the kit.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the country of Hong Kong.” 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 terminated this recall 2.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0818-2022 (January 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0818-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.