Lower riskMedical device recall · FDA · Published May 22, 2025
Integra Extended Tip Applicators Recall: Endotoxin Risk
Integra LifeSciences recalls 15cm Extended Tip Applicators (box of 5) due to potential endotoxin levels and lack of sterility. Affected units include all lots with model 205115.
“Integra Extended Tip Applicators Recall: Endotoxin Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52230-integra-extended-tip-applicators-recall-endotoxin-risk. Based on FDA recall #Z-1959-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1959-2025%22&limit=1).
The FDA announced on May 22, 2025, that Integra LifeSciences Corp. (NeuroSciences) is recalling Extended Tip Applicators due to potentially out-of-specification endotoxin levels and lack of sterility assurance. The voluntary Class I recall affects 2,524 units distributed domestically and internationally.
How to tell if you have it
Brand: Integra LifeSciences
Product: Extended Tip Applicator, 15 CM, Box of 5
Model/Catalog Number: 205115
UDI: 10381780000150
Lots: All Lots
The hazard
The devices contain potentially out-of-specification levels of endotoxins and lack sterility assurance. The FDA classified this as a Class I recall.
Context
GovInfoNow's records show Integra LifeSciences Corp. (NeuroSciences) has had 12 other recalls since April 4, 2025. Recent brand recalls include the OmniTract Surgical Retractor System on June 5, 2026, and the Codman CerebroFlo EVD Catheter on April 10, 2026. Other recent recalls of similar products include Medline Neuro Sponges (March 19, 2026), Medline Cervical Pack Kits (March 19, 2026), and Medline medical procedure kits (March 19, 2026).
How to tell if you have this one
Check for the model number 205115 on the box. All lots of this product are affected, including those with UDI 10381780000150.
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 I
Status
Ongoing
Distribution
Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran (Islamic Republic of), Ireland, Italy, Jordan, Malta, Netherlands (the), Nigeria, Palestine, State of, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey.
Recall number
Product, codes & lots
Quantity
Z-1958-2025
Extended Tip Applicator, 8CM, Box of 5.; Model/Catalog Number: 205108; UDI: 10381780000143; All Lots.
6,216 units
Z-1959-2025
Extended Tip Applicator, 15 CM, Box of 5.; Model/Catalog Number: 205115; UDI: 10381780000150; All Lots.
2,524 units
Z-1960-2025
Extended Tip Applicator 8CM, Box of 1.; Model/Catalog Number: 201108; UDI 10381780000167; All Lots.
212 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for model number 205115 on the box or UDI 10381780000150 to confirm affected units.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, 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 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
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-1959-2025 (May 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1959-2025 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.