FDA Device recall Z-0785-2025
Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C
- FDA Device
- Class II
- ongoing
- Published 2025-01-08
On 2025-01-08 the FDA classified a Class II recall of Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C by Medline Industries Northfield, citing custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0785-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-21 |
| Published | 2025-01-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
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
Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Identifiers
| code_info | 1) REF DYNJ36728C, UDI/DI 10193489265910(EA) (CS), Lot Numbers: 20EBK304, 20HBL260, 20LBA831, 20WBG513, 21DBK481, 21K…1) REF DYNJ36728C, UDI/DI 10193489265910(EA) (CS), Lot Numbers: 20EBK304, 20HBL260, 20LBA831, 20WBG513, 21DBK481, 21KBO816, 22BBJ543, 22FBD924, 22HBR956, 22KBJ095, 23BBF230, 23FBG752, 23HBI340, 23IBD038, 24CBG736, 24GBJ933; 2) REF DYNJ40644A, UDI/DI 10193489292176(EA) (CS), Lot Numbers: 20CMB952, 20HMB559, 20KMA468, 20KMB182, 20KMC866, 21AME524, 21DMA759, 21EME248, 21GMB592, 21HMC615, 21IMF418, 21JMA505, 21KMG859, 21LMF984; 3) REF DYNJ66449, UDI/DI 10193489356113(EA) (CS), Lot Numbers: 20EBN857, 20HBH423, 20HBN194. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0785-2025%22
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