Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF — Class II medical device recall Z-0785-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-01-08, distributed nationwide. Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical St
| Recall number | Z-0785-2025 |
|---|---|
| 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 | 2024-11-21 |
| Classified | 2024-12-30 |
| Reported by FDA | 2025-01-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA |
| Quantity | 1,086 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489265910, 10193489292176, 10193489356113 |
| Lot numbers | 20CMB952, 20EBK304, 20EBN857, 20HBH423, 20HBL260, 20HBN194, 20HMB559, 20KMA468, 20KMB182, 20KMC866, 20LBA831, 20WBG513, 21AME524, 21DBK481, 21DMA759, 21EME248, 21GMB592, 21HMC615, 21IMF418, 21JMA505, 21KBO816, 21KMG859, 21LMF984, 22BBJ543, 22FBD924, 22HBR956, 22KBJ095, 23BBF230, 23FBG752, 23HBI340, 23IBD038, 24CBG736, 24GBJ933 |
| Model numbers | DYNJ36728C, DYNJ40644A, DYNJ66449 |
Product
Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF DYNJ40644A; 3) ENDO SINUS PACK, REF DYNJ66449.
Reason for recall
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
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-0785-2025. 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.