Data Foundry

Medical device recalls 2026

Medline convenience kits labeled as: 1) MAJOR GYN PACK — Class II medical device recall Z-3024-2026

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 numberZ-3024-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMedline Industries, LP, Northfield, IL, United States
Recall initiated2026-07-10
Classified2026-08-26
Reported by FDA2026-09-02
DistributedNationwide (US)
Quantity663 kits
UPC / GTIN / UDI-DI10195327076344, 10195327678562, 10198459219221, 10198459302299, 10198459302329, 10198459302336, 10198459320682, 10198459326103, 10198459377419, 10198459425653, 10198459586385, 10198459697739, 10198459714511, 10198459729614, 40195327076345, 40195327678563, 40198459219222, 40198459302290, 40198459302320, 40198459302337, 40198459320683, 40198459326104, 40198459377410, 40198459425654, 40198459586386 and 3 more
Lot numbers25IBP079, 25IBR180, 25IBS529, 25IBU845, 25JBI549, 25KBH197, 25KBM427, 25LBC312, 25LBU940, 26ABI051, 26ADA465, 26BBB487, 26CBM128, 26CBQ902, 26CBT177, 26CLA636, 26DBF153, 26DBG173, 26DBL480, 26DBO888

Product

Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAVINCI, Medline Kit SKU DYNJ900949C; 5) THORACIC, Medline Kit SKU DYNJ903470G; 6) CV PART 1 AND 2, Medline Kit SKU DYNJ908879G; 7) GENERAL ROBOTIC, Medline Kit SKU DYNJ910178A; 8) AMB GYN LAPAROSCOPY KT, Medline Kit SKU DYNJ910281B; 9) DIEP FLAP, Medline Kit SKU DYNJ910832A; 10) C-SECTION, Medline Kit SKU DYNJ911236; 11) LAPAROTOMY, Medline Kit SKU DYNJ911243; 12) OPEN HEART A&B, Medline Kit SKU DYNJ911245; 13) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332; 14) TRANSPLANT LIVER BOWEL KIT-LF, Medline Kit SKU DYNJ911332A.

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-3024-2026. 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.