Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL… — Class II medical device recall Z-0784-2025
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-0784-2025 |
|---|---|
| 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 | 1,072 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489356793, 10193489367379, 10193489624182, 10193489688542, 10195327212124, 40193489356794, 40193489367370, 40193489624183, 40193489688543, 40195327212125 |
| Lot numbers | 19BDB193, 19EDD585, 19IDA770, 20AMA033, 20AMC750, 20EBN856, 20EMB449, 20JBG508, 20JBK503, 20JBT975, 20KBQ270, 20KMC595, 21ABK829, 21AMB129, 21EBP637, 21EBP646, 21JBO555, 21KBC098, 21KBV126, 21LBP144, 22KMD675, 23DMD129, 23HMG766, 23JMD938 |
| Model numbers | DYNJ58648B, DYNJ58648C, DYNJ58648D, DYNJ58648J, DYNJ66447 |
Product
Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447; 4) ENDOSCOPIC SKULL BASE, REF DYNJ58648D; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648J.
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-0784-2025. 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.