Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC… — Class II medical device recall Z-0783-2025
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-0783-2025 |
|---|---|
| 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 | 943 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489633924, 10193489686661, 10193489759372, 10193489884449, 10193489887167, 10193489986235, 10193489992014, 10195327104733, 10195327567538, 10195327689872, 10889942215904, 10889942741601, 40193489633925, 40193489686662, 40193489759373, 40193489884440, 40193489887168, 40193489986236, 40193489992015, 40195327104734, 40195327567539, 40195327689873, 40889942215905, 40889942741602 |
| Lot numbers | 19BBA689, 19CBD918, 19EBD435, 19EBL594, 19EKB321, 19FBG295, 19GBR466, 19GBS384, 19GKD099, 19JKA065, 19LBL885, 19LKB378, 20BBJ487, 20CBF683, 20DKA223, 20EKA239, 20FBC462, 20FBS328, 20FKB859, 20GKA150, 20HBN061, 20HKB438, 21ALA327, 21CBU514, 21DBO189, 21EBC333, 21EBI475, 21EBM629, 21EBN240, 21EMF317, 21FBP379, 21FBT340, 21FBT699, 21FBT700, 21FBT702, 21KBN245, 22ABE990, 22CLA236, 22CLA782, 22FBV019 and 33 more |
| Model numbers | DYNJ0991320J, DYNJ21927R, DYNJ40406A, DYNJ51818F, DYNJ58648F, DYNJ66867A, DYNJ905366A, DYNJ905634B, DYNJ907817, DYNJ908165, DYNJ910072, DYNJ910120A |
Product
Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648F; 6) DIEP FLAP, REF DYNJ66867A; 7) KIT FREE FLAP MOSES, REF DYNJ905366A; 8) FREE FLAP, REF DYNJ905634B; 9) ROBOTIC THORACIC, REF DYNJ907817; 10) TRANSPHENOIDAL, REF DYNJ908165; 11) METREX, REF DYNJ910072; 12) DIEP FLAP, REF DYNJ910120A.
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-0783-2025. 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.