Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAG... — FDA record Z-1611-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 3, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Classification
Class II
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
21935 units
Agency-reported status
Ongoing
Source record identifier
Z-1611-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability1) DYNJ26971L, UDI-DI: 10198459087158(each), 40198459087159(case), Lot Number: 24IBD872; 2) DYNJ0378319P, UDI-DI: 10198459105722(each), 40198459105723(case), Lot Number: 24IBF374; 3) DYNJ64017B, UDI-DI: 10195327550325(each), 40195327550326(case), Lot Number: 24IBG070; 4) DYNJHTLD04A, UDI-DI: 10193489303346(each), 40193489303347(case), Lot Number: 24IBH288; 5) HM190A, UDI-DI: 10195327305161(each), 40195327305162(case), Lot Number: 24IBH818; 6) SYNJ10248B, UDI-DI: 10193489373387(each), 40193489373388(case), Lot Number: 24IBH820; 7) DYNJ84209, UDI-DI: 10195327342739(each), 40195327342730(case), Lot Number: 24IBH988; 8) DYNJ49542B, UDI-DI: 10195327388072(each), 40195327388073(case), Lot Number: 24IBR452; 9) DYNJ37124C, UDI-DI: 10195327416195(each), 40195327416196(case), Lot Number: 24IBR491; 10) DYNJ65689, UDI-DI: 10193489284836(each), 40193489284837(case), Lot Number: 24IBR570; 11) DYNJ43737D, UDI-DI: 10193489350845(each), 40193489350846(case), Lot Number: 24IBR650; 12) DYNJ0731657M, UDI-DI: 10195327697020(each), 40195327697021(case), Lot Number: 24IBR661; 13) DYNJ43604B, UDI-DI: 10193489997521(each), 40193489997522(case), Lot Number: 24IBR707; 14) DYNJ24276C, UDI-DI: 10884389431184(each), 40884389431185(case), Lot Number: 24IBS408; 15) DYNJ80304, UDI-DI: 10195327022532(each), 40195327022533(case), Lot Number: 24IBS686; 16) CDS982762I, UDI-DI: 10193489942095(each), 40193489942096(case), Lot Number: 24JBB609; 17) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24JBE762; 18) DYNJ43677D, UDI-DI: 10193489768589(each), 40193489768580(case), Lot Number: 24JBM324; 19) DYNJ43677D, UDI-DI: 10193489768589(each), 40193489768580(case), Lot Number: 24JBM600; 20) DYNJ47625B, UDI-DI: 10889942182589(each), 40889942182580(case), Lot Number: 24JBN320; 21) DYNJ03387B, UDI-DI: 10195327191092(each), 40195327191093(case), Lot Number: 24JBO026; 22) DYNJHTLD04A, UDI-DI: 10193489303346(each), 40193489303347(case), Lot Number: 24JBR630; 23) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24JBU227; 24) DYNJ23158B, UDI-DI: 10195327473891(each), 40195327473892(case), Lot Number: 24JBU459; 25) DYNJHTLD03A, UDI-DI: 10193489303353(each), 40193489303354(case), Lot Number: 24JBU555; 26) DYNJ43737D, UDI-DI: 10193489350845(each), 40193489350846(case), Lot Number: 24JBV052; 27) DYNJ34949, UDI-DI: 10884389403358(each), 40884389403359(case), Lot Number: 24JBV802; 28) DYNJ55835B, UDI-DI: 10195327319946(each), 40195327319947(case), Lot Number: 24JBV820; 29) DYNJ68778A, UDI-DI: 10198459035852(each), 40198459035853(case), Lot Number: 24JBV866; 30) DYNJ83115, UDI-DI: 10195327232979(each), 40195327232970(case), Lot Number: 24JBV884; 31) DYNJ65689, UDI-DI: 10193489284836(each), 40193489284837(case), Lot Number: 24JBW792; 32) DYNJ64828B, UDI-DI: 10198459140280(each), 40198459140281(case), Lot Number: 24JBX788; 33) DYNJ69433, UDI-DI: 10193489940985(each), 40193489940986(case), Lot Number: 24JBX797; 34) DYNJS8250, UDI-DI: 10884389349298(each), 40884389349299(case), Lot Number: 24KBA046; 35) DYNJ24514G, UDI-DI: 10193489893656(each), 40193489893657(case), Lot Number: 24KBA388; 36) DYNJ63270C, UDI-DI: 10193489862614(each), 40193489862615(case), Lot Number: 24KBB101; 37) DYNJ80329, UDI-DI: 10195327027193(each), 40195327027194(case), Lot Number: 24KBB586; 38) DYNJ40009D, UDI-DI: 10195327362362(each), 40195327362363(case), Lot Number: 24KBC597; 39) DYNJ45589F, UDI-DI: 10198459125904(each), 40198459125905(case), Lot Number: 24KBC628; 40) DYNJ82620A, UDI-DI: 10198459150081(each), 40198459150082(case), Lot Number: 24KBC810; 41) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24KBD009; 42) DYNJ69964, UDI-DI: 10195327000660(each), 40195327000661(case), Lot Number: 24KBE397; 43) DYNJ34315D, UDI-DI: 10198459168369(each), 40198459168360(case), Lot Number: 24KBF136; 44) DYNJ57668A, UDI-DI: 10193489795622(each), 40193489795623(case), Lot Number: 24KBG150; 45) DYNJ35608K, UDI-DI: 10195327099022(each), 40195327099023(case), Lot Number: 24KBG823; 46) DYNJ07520J, UDI-DI: 10198459015533(each), 40198459015534(case), Lot Number: 24KBG847; 47) DYNJ84209, UDI-DI: 10195327342739(each), 40195327342730(case), Lot Number: 24KBG879; 48) DYNJ68778A, UDI-DI: 10198459035852(each), 40198459035853(case), Lot Number: 24KBH870; 49) DYNJC9242C, UDI-DI: 10193489568882(each), 40193489568883(case), Lot Number: 24KBL933; 50) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24KBN086; 51) DYNJ907958, UDI-DI: 10193489949445(each), 40193489949446(case), Lot Number: 24KBQ773; 52) DYNJ908581A, UDI-DI: 10195327594664(each), 40195327594665(case), Lot Number: 24KBU702; 53) DYNJC9242C, UDI-DI: 10193489568882(each), 40193489568883(case), Lot Number: 24LBK538; 54) DYNJ903796C, UDI-DI: 10195327623371(each), 40195327623372(case), Lot Number: 24LBO942; 55) DYNJ907958, UDI-DI: 10193489949445(each), 40193489949446(case), Lot Number: 25ABA840

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Apr 23, 2025
Recall initiation date
Mar 3, 2025
Center classification date
Apr 17, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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