Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS — Class II medical device recall Z-0779-2025
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-0779-2025 |
|---|---|
| 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 | 1,402 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489222432, 10193489254273, 10193489275339, 10193489353532, 10193489377026, 10195327073749, 10889942085088, 40193489222433, 40193489254274, 40193489275330, 40193489353533, 40193489377027, 40195327073740, 40889942085089 |
| Lot numbers | 19AKC072, 19HKC645, 19KKA304, 20AKA332, 20BDB519, 20BKA860, 20EDA360, 20EDC040, 20EKB648, 20FKA539, 20GDA474, 20HBU444, 20HBW312, 20HKA426, 20JDA107, 20JKA217, 20KDA855, 20LKB026, 21CDA110, 21EBD895, 21EDA674, 21FBE508, 21FBT545, 21FDA748, 21HBL828, 21HBS523, 21KBY910, 21KBY914, 21LDA084, 22CBJ951, 22HBJ403, 22LBQ584, 23BBH164, 23CBG816, 23FBM524 |
| Model numbers | CDS983470D, DYNJ0713177, DYNJ56819D, DYNJ56819F, DYNJ56819G, PHS392834010D, YNJ10307A |
Product
Medline custom medical procedure kits labeled as: 1) VP SHUNT CDS, REF CDS983470D; 2) 1/2X1/2 NEURO SPONGE PACK-LF, REF DYNJ0713177; 3) BURR HOLE SHUNT PACK, REF DYNJ56819D; 4) BURR HOLE SHUNT PACK, REF DYNJ56819F; 5) BURR HOLE SHUNT PACK, REF DYNJ56819G; 6) RO VP SHUNT PACK, REF PHS392834010D; 7) VP SHUNT, REF SYNJ10307A.
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-0779-2025. 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.