Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF — Class II medical device recall Z-0777-2025
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-0777-2025 |
|---|---|
| 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 | 1,236 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489288384, 10193489324785, 10193489887853, 10889942063994, 10889942798278, 40193489288385, 40193489324786, 40193489887854, 40889942798279 |
| Lot numbers | 19BDC737, 19FDA310, 19FDB230, 19JDA441, 19TBC792, 20CKA219, 20CKA875, 20DBK065, 20EKB076, 20FBN251, 20GKA543, 20GKB272, 20HBL176, 20HBM692, 20IKB497, 20JKB716, 21AKA500, 21BKA195, 21CBP776, 21FMD808, 21HMD657, 21IBN151, 21IMB172, 21JMH627, 21KBO915, 21KMH877, 21LBJ105, 21LMC161, 21VBB714, 22AMA533, 22DMC612, 22DMI233, 22GMB685, 22IMA041, 22OBL262, 23AMD730, 23DMA094, 23FMF542, 23IME618, 24AMA230 |
| Model numbers | DYNJ0382559M, DYNJ0578916X, DYNJ56001B, DYNJ66252, DYNJ66252A |
Product
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.
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-0777-2025. 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.