Medline Convenience kits used for various procedures: 1) LABOR AND… — Class II medical device recall Z-1611-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-23, distributed nationwide. There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile co
| Recall number | Z-1611-2025 |
|---|---|
| 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 | 2025-03-03 |
| Classified | 2025-04-17 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX, PA |
| Quantity | 21,935 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489284836, 10193489303346, 10193489303353, 10193489350845, 10193489373387, 10193489568882, 10193489768589, 10193489795622, 10193489862614, 10193489893656, 10193489940985, 10193489942095, 10193489949445, 10193489997521, 10195327000660, 10195327022532, 10195327027193, 10195327099022, 10195327191092, 10195327232979, 10195327305161, 10195327319946, 10195327342739, 10195327362362, 10195327388072 and 63 more |
| Lot numbers | 24IBD872, 24IBF374, 24IBG070, 24IBH288, 24IBH818, 24IBH820, 24IBH988, 24IBR452, 24IBR491, 24IBR570, 24IBR650, 24IBR661, 24IBR707, 24IBS408, 24IBS686, 24JBB609, 24JBE762, 24JBM324, 24JBM600, 24JBN320, 24JBO026, 24JBR630, 24JBU227, 24JBU459, 24JBU555, 24JBV052, 24JBV802, 24JBV820, 24JBV866, 24JBV884, 24JBW792, 24JBX788, 24JBX797, 24KBA046, 24KBA388, 24KBB101, 24KBB586, 24KBC597, 24KBC628, 24KBC810 and 15 more |
| Model numbers | CDS982762I, DYNJ03387B, DYNJ0378319P, DYNJ0731657M, DYNJ07520J, DYNJ23158B, DYNJ24276C, DYNJ24514G, DYNJ26971L, DYNJ34315D, DYNJ34949, DYNJ35608K, DYNJ37124C, DYNJ40009D, DYNJ43604B, DYNJ43677D, DYNJ43737D, DYNJ45589F, DYNJ47625B, DYNJ49542B, DYNJ55835B, DYNJ57668A, DYNJ63270C, DYNJ64017B, DYNJ64828B and 19 more |
Product
Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number: DYNJ64017B; 4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 5) PACK VAGINAL DELIVERY, Model Number: HM190A; 6) VAGINAL DELIVERY PACK, Model Number: SYNJ10248B; 7) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209; 8) VAG DELIVERY PACK-6220, Model Number: DYNJ49542B; 9) FHT VAG DELIVERY PACK, Model Number: DYNJ37124C; 10) VAGINAL DEL PK, Model Number: DYNJ65689; 11) PK,L&D-VAG DEL, Model Number: DYNJ43737D; 12) L&D PACK-LF, Model Number: DYNJ0731657M; 13) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ43604B; 14) VAD ACCESS, Model Number: DYNJ24276C; 15) VAGINAL DELIVERY PACK, Model Number: DYNJ80304; 16) VAGINAL DELIVERY CDS, Model Number: CDS982762I; 17) VAGINAL DELIVERY, Model Number: DYNJ903796C; 18) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D; 19) VAGINAL DELIVERY PACK, Model Number: DYNJ43677D; 20) BR L&D PACK, Model Number: DYNJ47625B; 21) OB PACK, Model Number: DYNJ03387B; 22) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 23) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 24) VAGINAL DELIVERY PACK, Model Number: DYNJ23158B; 25) L AND D PACK, Model Number: DYNJHTLD03A; 26) PK,L&D-VAG DEL, Model Number: DYNJ43737D; 27) VAG DELIVERY PACK, Model Number: DYNJ34949; 28) OB PACK, Model Number: DYNJ55835B; 29) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A; 30) OB PACK, Model Number: DYNJ83115; 31) VAGINAL DEL PK, Model Number: DYNJ65689; 32) LDRP-OBSTETRICAL PACK-LF, Model Number: DYNJ64828B; 33) LABOR & DELIVERY PACK, Model Number: DYNJ69433; 34) LABOR & DELIVERY II-LF, Model Number: DYNJS8250; 35) VAGINAL DELIVERY PACK-MARY IMM, Model Number: DYNJ24514G; 36) CUSTOM VAGINAL DELIVERY, Model Number: DYNJ63270C; 37) BHS STANDARD VAGINAL DELIVERY, Model Number: DYNJ80329; 38) OB VAGINAL PACK-LF, Model Number: DYNJ40009D; 39) DELIVERY PACK ME-LF RF, Model Number: DYNJ45589F; 40) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ82620A; 41) VAGINAL DELIVERY, Model Number: DYNJ903796C; 42) DELIVERY PACK, Model Number: DYNJ69964; 43) VAGINAL DELIVERY PACK, Model Number: DYNJ34315D; 44) VAGINAL DELIVERY PACK, Model Number: DYNJ57668A; 45) VAG DELIVERY PACK CHS-LF, Model Number: DYNJ35608K; 46) O.B. PACK-LF, Model Number: DYNJ07520J; 47) OB PROTECTION PACK NO GAUZE, Model Number: DYNJ84209; 48) VAGINAL DELIVERY PACK, Model Number: DYNJ68778A; 49) CUH VAGINAL-LF, Model Number: DYNJC9242C; 50) VAGINAL DELIVERY, Model Number: DYNJ903796C; 51) VAGINAL DELIVERY, Model Number: DYNJ907958; 52) VAG DEL PROCEDURE MCSETX, Model Number: DYNJ908581A; 53) CUH VAGINAL-LF, Model Number: DYNJC9242C; 54) VAGINAL DELIVERY, Model Number: DYNJ903796C; 55) VAGINAL DELIVERY, Model Number: DYNJ907958
Reason for recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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-1611-2025. 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.