Class II — Windstone Medical Packaging, Inc.
| Recalling firm | WINDSTONE MEDICAL PACKAGING, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare. |
| Product | 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 AMS12343A Meldrum Pack AMS12359B Neuro Pack AMS12520 Total Hip Pack AMS12608 Extremity Pack AMS12610 Shoulder Pack AMS12636 Dr. Thompson Pack AMS12689A Custom Pack AMS12753 Breast Pack AMS12754 Abdominoplasty Pack AMS12769 Minor Pack AMS12926 Shoulder Pack AMS12927 Retina Pack AMS13428 Hand P… |
| Quantity | 9,489 kits |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AZ, CA, CO, CT, FL, Guam, IN, NC, NJ, NV, OK PA, TN, TX, and WI. The country of Canada. |
| Initiated | 2022-11-01 |
| Classified | 2023-01-04 |
| Recall number | Z-0881-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Windstone Medical Packaging, Inc. (Z-0881-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91157/
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