AMS Convenience Kit: DSAEK Pack — Class II medical device recall Z-3138-2026
Ongoing recall by Windstone Medical Packaging, Inc., reported 2026-09-16, distributed nationwide. The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which
| Recall number | Z-3138-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Windstone Medical Packaging, Inc., Billings, MT, United States |
| Recall initiated | 2026-07-29 |
| Classified | 2026-09-10 |
| Reported by FDA | 2026-09-16 |
| Distributed | Nationwide (US) |
| Quantity | 3,260 kits |
| Reason classes | device malfunction |
| Lot numbers | 223913, 223914, 223915, 223916, 225275, 225276, 225455, 226382, 226572, 226714, 226841, 226897, 226969, 227112, 227540, 227828, 228263, 228572, 228718, 228793, 229140, 229141, 229238, 229390, 229565, 229655, 229656, 229824, 229825, 229977, 230098, 230694, 230695, 230696, 230697, 230968, 230969, 230970, 231080, 231081 and 43 more |
| Model numbers | AMS12394B |
Product
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3138-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.