MEDLINE INDUSTRIES, LP - Northfield: Device Recall

Recall Details

Recall Number

Z-1611-2025

Classification

Class II

Product Type

Device

Recalling Firm

MEDLINE INDUSTRIES, LP - Northfield

Status

Ongoing

Date Initiated

03/03/2025

Location

Northfield, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

21935 units

Reason for Recall

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

Product Description

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

Distribution Pattern

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

Other Recalls by MEDLINE INDUSTRIES, LP - Northfield

• Class I: Dangerous 07/25/2025
  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
• Class I: Dangerous 07/25/2025
  Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
• Class II: Risk 07/23/2025
  Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).
• Class I: Dangerous 07/14/2025
  Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
• Class II: Risk 07/08/2025
  Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.

View all recalls by MEDLINE INDUSTRIES, LP - Northfield →