Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y… — Class II medical device recall Z-2418-2026
Ongoing recall by Medline Industries, LP, reported 2026-06-24, distributed nationwide. Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during
| Recall number | Z-2418-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2026-04-27 |
| Classified | 2026-06-12 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 49,654 kits |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10198459303029, 10198459325663, 10198459385582, 10198459422133, 10198459443114, 10198459452581, 10198459513954, 10198459528002, 10198459579813, 10198459580888, 10198459582035 |
| Lot numbers | 25JBW220, 25KBA098, 25KBG761, 25KBM758, 25KBM870, 25KBO682, 25LBF702, 25LMH549, 25LMJ874, 26AMA072, 26BBB926, 26BBD028, 26CBC302, CDS840150Y, CDS983040M, CVI5323A, DYNJ33822L, DYNJ54238L, DYNJ56297C, DYNJ900962O, DYNJ909794C, DYNJT3454, DYNJT6766 |
Product
Medline convenience kits: LOOP PACK DYNJ61460C OPEN HEART CDS840150Y PACEMAKER DYNJ56297C PACEMAKER PK DYNJT3454 PACEMAKER/ICD PACK DYNJ33822L PAD OPEN HEART DYNJ900962O PEDIATRIC OPEN HEART DYNJ54238L DYNJT6766 STAZ BASIC VASCULAR DYNJ909794C VASCULAR ACCESS KIT CVI5323A VASCULAR CDS CDS983040M
Reason for recall
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
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-2418-2026. 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.