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

Recall Z-0881-2023 — Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack AMS12341B Hassan Pack AMS12

U.S. FDA — Device Enforcement · United States · 2022-11-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0881-2023
Date of alert: 2022-11-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Windstone Medical Packaging, Inc.
Product category: device
Product type: Devices

Reported risk: Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.

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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