Medline brand — Class II medical device recall Z-0724-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-01-01, distributed nationwide. Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-th
| Recall number | Z-0724-2025 |
|---|---|
| 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 | 2024-11-06 |
| Classified | 2024-12-20 |
| Reported by FDA | 2025-01-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 12,889 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489324402, 10193489370690, 10193489426984, 10193489453355, 10193489477177, 10193489510324, 10193489880564, 10193489908725, 10193489932386, 10195327068325, 10195327080365, 10195327081324, 10195327211028, 10195327262945, 10195327281250, 10195327345129, 10195327365684, 10195327465636, 10195327548940, 10195327690342, 10198459025631, 10198459082702, 10888277762688, 10889942265886, 10889942765256 and 25 more |
| Lot numbers | 20CMA256, 20CMC383, 20DBF296, 20EBG032, 20EBU829, 20EMB420, 20FBW118, 20GMD367, 20HBA904, 20HBM398, 20HMB030, 20JBF504, 20JMB588, 20LBO578, 20LMD710, 21ABD769, 21ABF202, 21BMB573, 21BMC249, 21BMD492, 21BMD698, 21CMA323, 21CMD623, 21CME103, 21DME512, 21EBS026, 21EBS045, 21EMB917, 21EME688, 21GMC844, 21GMC966, 21GMF465, 21HMA330, 21HMB808, 21IBO584, 21IMA074, 21IMB620, 21IMG224, 21JMB244, 21JMB245 and 88 more |
Product
Medline brand, medical procedure convenience kits, labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, SKU CDS780119T; 2) NEURO KIT, SKU CDS981327Q; 3) NEURO POSTERIOR SPINE PACK-LF, SKU DYNJ0311501I; 4) ACOUSTIC NEUROMA PACK-LF, SKU DYNJ37741D; 5) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836C; 6) SCRIPPS SW NEURO PACK-LF, SKU DYNJ39836D; 7) NEURO BUNDLE-LF, SKU DYNJ40095A; 8) NEURO BUNDLE-LF, SKU DYNJ40095B; 9) NEURO BUNDLE-LF, SKU DYNJ40095C; 10) NEURO BUNDLE-LF, SKU DYNJ40095D; 11) NEURO PACK-LF, SKU DYNJ42844D; 12) WMC VP SHUNT PACK-LF, SKU DYNJ50629J; 13) NEURO PACK, SKU DYNJ54255A; 14) NEURO CHRISTUS, SKU DYNJ61190A; 15) NEURO KIT, SKU DYNJ62854B; 16) NEURO KIT, SKU DYNJ62854C; 17) NEURO PACK NTX, SKU DYNJ66213D; 18) NEURO PACK, SKU DYNJ67628C; 19) BASIC NEURO CUSTOM, SKU DYNJ83387; 20) BASIC NEURO CUSTOM, SKU DYNJ83387A; 21) HALY NEURO PACK, SKU DYNJ87308; 22) FHWC NEURO, SKU DYNJ906131B; 23) CRANI, SKU DYNJ907865; 24) KIT NEURO LAFAYETTE, SKU DYNJ908615C; 25) GENERAL NEURO, SKU DYNJ909744
Reason for recall
Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
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-0724-2025. 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.