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

Recall Z-0657-2025 — Ambler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during surgical procedure

U.S. FDA — Device Enforcement · United States · 2024-11-14 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0657-2025
Date of alert: 2024-11-14
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Kirwan Surgical Products, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00190660001025

Reported risk: Potential for the outer stainless-steel tube to break or detach.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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.

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