Medline convenience kits labeled as: 1) OPEN HEART PACK — Class II medical device recall Z-3020-2026
Ongoing recall by Medline Industries, LP, reported 2026-09-02, distributed nationwide. Kits contain a potentially contaminated component which were recalled by the manufacturer
| Recall number | Z-3020-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-07-10 |
| Classified | 2026-08-26 |
| Reported by FDA | 2026-09-02 |
| Distributed | Nationwide (US) |
| Quantity | 263 kits |
| UPC / GTIN / UDI-DI | 10198459123542, 10198459168499, 10198459208928, 10198459275814, 10198459308581, 10198459361616, 10198459385605, 10198459405266, 10198459504877, 10198459791673, 40198459123543, 40198459168490, 40198459208929, 40198459275815, 40198459308582, 40198459361617, 40198459385606, 40198459405267, 40198459504878, 40198459791674 |
| Lot numbers | 25IMG539, 25JBM122, 25JBR361, 25JBS919, 25JBY147, 25JME689, 25JMF804, 25KBD555, 25KBF034, 25KLA552, 25LLA196, 25LLA516, 25LLA930, 25LMG706, 25LMH727, 26FMA487, 26GMA017 |
Product
Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W; 6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F; 7) PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C; 8) ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F; 9) OPEN HEART, Medline Kit SKU DYNJ910947; 10) CV, Medline Kit SKU DYNJ911488.
Reason for recall
Kits contain a potentially contaminated component which were recalled by the manufacturer
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-3020-2026. 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.