Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1958-2025 — Extended Tip Applicator, 8CM, Box of 5.

U.S. FDA — Device Enforcement · United States · 2025-05-22 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1958-2025
Date of alert: 2025-05-22
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Integra LifeSciences Corp. (NeuroSciences)
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10381780000143

Reported risk: Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1958-2025 — Extended Tip Applicator, 8CM, Box of 5.

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