CLASS I ONGOING Device recall · Reported 2 Jul 2025 · FDA Enforcement Report
Extended Tip Applicator, Box recalled by Integra LifeSciences Corp.
Integra LifeSciences Corp. (NeuroSciences) is recalling Extended Tip Applicator, Box of 5, distributed nationwide in the US. The recall was initiated on 22 May 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1959-2025
- FDA event ID
- 96934
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences), Princeton, NJ
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 22 May 2025
- FDA classified
- 20 Jun 2025
- Reported
- 2 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 22 May 2025 | Recall initiated by company | |
| 20 Jun 2025 | Classified by FDA | +29 days |
| 2 Jul 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Extended Tip Applicator, 15 CM, Box of 5.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
Which lots are affected?
Model/Catalog Number: 205115; UDI: 10381780000150; All Lots.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 96934| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Extended Tip Applicator, Box recalled by Integra LifeSciences Corp. | Integra LifeSciences Corp. (NeuroSciences) | Sterility | Nationwide | |
| CLASS I | Extended Tip Applicator, Box recalled by Integra LifeSciences Corp. | Integra LifeSciences Corp. (NeuroSciences) | Sterility | Nationwide |
More recalls from Integra LifeSciences Corp. (NeuroSciences)
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | OmniTract Surgical Retractor System recalled | Integra LifeSciences Corp. (NeuroSciences) | Sterility | Nationwide |
| Device | CLASS II | Codman CerebroFlo EVD Catheter with Endexo Technology recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide |
| Device | CLASS II | CUSA Clarity C7000 Console recalled by Integra LifeSciences Corp. | Integra LifeSciences Corp. (NeuroSciences) | Device Malfunction | Nationwide |
| Device | CLASS II | Cytal Wound Matrix 2-Layer cm. Product ID: WSM1015 recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide |
| Device | CLASS II | Cytal Wound Matrix 2-Layer cm. Product ID: WSM0710 recalled | Integra LifeSciences Corp. (NeuroSciences) | Other | Nationwide |
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