Medline PEDIATRIC DRAPE PK — Class II medical device recall Z-0169-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-10-30, distributed nationwide. It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may re
| Recall number | Z-0169-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-09-04 |
| Classified | 2024-10-23 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 150 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10195327108083, 40195327108084 |
| Lot numbers | 23LBL738 |
| Model numbers | DYNJ81297 |
Product
Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit
Reason for recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
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-0169-2025. 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.