Medline brand — Class II medical device recall Z-0156-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-10-30, distributed nationwide. It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may re
| Recall number | Z-0156-2025 |
|---|---|
| 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 | 2024-09-04 |
| Classified | 2024-10-23 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 2,631 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10193489374377, 10193489374490, 10193489517071, 10193489677348, 10193489906233, 10193489916331, 10193489980110, 10195327009250, 10195327164676, 10195327333768, 10195327486426, 10195327515942, 10195327547608, 10195327555948, 10884389861684, 10888277036345, 10888277744806, 10888277890602, 10889942279296, 10889942621552, 10889942648054, 10889942670840, 40193489374378, 40193489374491, 40193489517072 and 19 more |
| Lot numbers | 23EBD843A, 23KBB860, 23LBI662, 23LBK382, 23LBL339, 23LBL628, 23LBL699, 23LBM830, 23LBP126, 23LBP174, 23LBP442, 23LBQ949, 23LBR317, 23LBR843, 23LBS865, 24ABA421, 24ABB296, 24ABD377, 24ABF463, 24ABN040, 24ABN915, 24ABV352, 24BBA256 |
| Model numbers | CDS983202I, DYNDC2486A, DYNJ01201L, DYNJ0537343G, DYNJ32727A, DYNJ32915B, DYNJ35884C, DYNJ36241K, DYNJ38084B, DYNJ40488, DYNJ41925G, DYNJ46745A, DYNJ49874, DYNJ56235, DYNJ66718A, DYNJ69012C, DYNJ69196, DYNJ80064, DYNJ903814B, DYNJ908126, YNJ10322A, YNJ910026A |
Product
Medline brand, medical procedure convenience kits, labeled as: a) CUH OPEN HEART A B C - CDS, REF CDS983202I; a) PICC INSERTION KIT, REF DYNDC2486A; a) OPEN HEART PACK, REF DYNJ01201L; a) BREAST/CHEST SHEET PACK-LF, REF DYNJ0537343G; a) COTTON ROLL KIT-LF, REF DYNJ32727A; a) VASCULAR PACK-LF, REF DYNJ32915B; a) SUAREZ AVR/MVR PACK, REF DYNJ35884C; a) VALVE ACCESSORY PACK, REF DYNJ36241K; a) ENSEMBLE ABDO-PERINEAL-LF, REF DYNJ38084B; a) EP PACK, REF DYNJ40488; a) PACEMAKER PACK SMGH-LF, REF DYNJ41925G; a) PACEMAKER TEGH-LF, REF DYNJ46745A; a) VEIN AND LASER PACK, REF DYNJ49874; a) DR NACKMAN VEIN PACK, REF DYNJ56235; a) NEUROVASCULAR PACK, REF DYNJ66718A; a) VEIN TRAY, REF DYNJ69012C; a) LOOP RECORDER-LF, REF DYNJ69196; a) U BAR DRAPE, REF DYNJ80064; a) ENDO, REF DYNJ903814B; a) CARDIAC PROCEDURE, REF DYNJ908126; a) CARDIAC PROCEDURE, REF DYNJ908126; a) VASCULAR EXTREMITY PACK, REF SYNJ10322A; a) VASCULAR EXTREMITY, REF SYNJ910026A
Reason for recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
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-0156-2025. 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.