Integra LifeSciences recalls Bactisal EVD catheter sets with packaging defects that may compromise sterility. Affected units include specific lot numbers and product codes for brain ventricle access procedures.
“Integra Bactisal EVD Catheter Set Recall: Packaging Defect Risks Sterility Compromise.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55165-integra-bactisal-evd-catheter-set-recall-packaging-defect-risks-sterility. Based on FDA recall #Z-2136-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2136-2024%22&limit=1).
The FDA announced on May 7, 2024, that Integra LifeSciences Corp. is recalling CODMAN BACTISEAL EVD Catheter Sets due to defective external sterile packaging that may compromise product sterility. The recall affects 135 units distributed worldwide.
How to tell if you have it
Brand: Integra LifeSciences
Product: CODMAN BACTISEAL EVD Catheter Set
Product Number: 821745
UDI-DI: 10381780515593
Lot numbers: 7320001, 7320004, 720005, 7322926, 322927
The hazard
The defect involves a gap or weakness in the seal of the external sterile packaging pouch. This issue may compromise the sterility of the CODMAN BACTISEAL EVD Catheter Set, which is indicated for gaining access to the ventricles of the brain.
Context
GovInfoNow's records show Integra LifeSciences Corp. has issued 35 other recalls since August 18, 2017. Recent brand recalls include an AURORA Surgiscope System recall on February 6, 2025, for a risk of obturator breaking, and a MediHoney Wound Dressing Gel recall on January 10, 2025, regarding induction seal packaging risks. Other recent recalls of similar products include Stryker BARD Dynamic Deca Steerable Catheter Recall (April 10, 2026) and Stryker BARD EP XT Steerable Catheter Recall (April 10, 2026).
How to tell if you have this one
Check for product number 821745 and lot numbers 7320001, 7320004, 720005, 7322926, or 322927. The catheter set is used for brain ventricle access procedures.
Brand
Integra LifeSciences
Category
Medical device
FDA recall event · 3 products
All 3 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
Ongoing
Distribution
Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey
Recall number
Product, codes & lots
Quantity
Z-2136-2024
CODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821745; UDI-DI: 10381780515593 Lot numbers: 7320001, 7320004, 720005, 7322926, 322927
135 units
Z-2137-2024
CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821749; UDI-DI: 10381780518440 Lot numbers: 7314912, 7320010, 7322933
106 units
Z-2138-2024
CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821750; UDI-DI: 10381780518457 Lot Numbers: 7314916, 7314917, 7322939, 7328498, 7328563, 7328566, 7328569
59 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product number (821745) and lot numbers (7320001, 7320004, 720005, 7322926, 322927) to confirm if your set is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the state of TX and the countries of Canada, China, Croatia, Hungary, Russia, Singapore, Slovenia, South Africa, Taiwan (Province of China), Turkey” 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 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2136-2024 (May 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2136-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.