FDA Medical devices recall · April 23, 2025

Medline Convenience kits used for various procedures: 1) LABOR AND… recall

Read the official FDA notice ↗

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

Why was it recalled?

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

1) 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), Lo

Distribution

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

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1611-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.