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Windstone Medical Packaging, Inc. recalls

The FDA has posted 22 enforcement recalls from Windstone Medical Packaging, Inc. since 2025, including 5 Class I (most serious) recalls. Most recent report: Sep 16, 2026.

Class I: 5Class II: 17
Class IIOngoingZ-3138-2026

Windstone Medical Packaging, Inc. recalls AMS Convenience Kit: DSAEK Pack - RX

The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.

  • Disposable Surgical Instrument Kit
  • Equipment maintenance
Windstone Medical Pack…MTSep 16, 2026

Firm name as filed with the FDA: “Windstone Medical Packaging, Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.