The Recall Desk

FDA (Devices) recall action 96510

MEDLINE INDUSTRIES, LP - Northfield recalled 34 products on 2025-04-23

The FDA (Devices) publishes a recall like this one as 34 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 34 pages.

Products
34
Announced
2025-04-23
Critical
0
Units
115,571

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–25 of 34

  • ModerateFDA (Devices)··2025-04-23

    Medline Sterile Convenience Kits Recalled for Open Breather Pouches

    Medline Industries is recalling three models of sterile convenience kits used for arthroscopy procedures due to potential open or weak seals on the breather pouches used for packaging.

    Product
    Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GENOU-LF, Model Number: DYNJ40229A; 2) ARTHROSCOPY PACK-LF, Model Number: OPK382N; 3) ARTHROSCOPY NEW TEGH-LF, Model Number: DYNJ46723B
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline sterile convenience kits recalled for potentially weak packaging seals

    Medline is recalling three sterile convenience kit models due to potentially open or weak seals on the breather pouches used for packaging. The affected kits are distributed worldwide, including the US, Canada, Mexico, Panama, and the Virgin Islands.

    Product
    Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2025-04-23

    Medline Convenience Kits Recalled for Potentially Open Breather Pouches

    Medline Industries is recalling select sterile convenience kits because purchased breather pouches used for packaging may have open or weak seals, potentially compromising the sterility of the kits.

    Product
    Medline Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6) PPM-IC
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline pacemaker drape pack convenience kits recalled for seal defects

    Medline is recalling its Custom Pacemaker Drape Pack (Model DYNJCD0339) due to potential weak or open seals on breather pouches used in sterile convenience kits.

    Product
    Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAPE PACK, Model Number: DYNJCD0339
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals

    Medline Industries is recalling multiple sterile surgical convenience kits due to potential open or weak seals on the breather pouches used for packaging. The compromised seals could affect product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B; 4) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 5) PE
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals

    Medline Industries is recalling multiple sterile convenience kits used for obstetric and gynecological procedures due to potential weak or open seals on breather pouches, which could compromise product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040;
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals

    Medline Industries is recalling sterile convenience kits with select breather pouches that may have open or weak seals, potentially compromising sterility. Affected units were distributed worldwide, including the US, Canada, Mexico, Panama, and the Virgin Islands.

    Product
    Refer to RES
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline Convenience Kits Recalled Due to Weak Breather Pouch Seals

    Medline Industries is recalling multiple convenience kit models due to potential open or weak seals on breather pouches used for packaging. The compromised seals may allow sterility to be compromised on these medical device kits distributed nationwide and internationally.

    Product
    Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF, Model Number: DYNJ41682C; 3) SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267A; 4) ILR INSERTION-REMOVAL PACK, Model Number: DYNJ8243
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline Convenience Kits Recalled for Potential Open or Weak Seals

    Medline Industries is recalling select sterile convenience kits due to potential open or weak seals on breather pouches used for packaging. The defect may compromise product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP PACK-LF, Model Number: DYNJ0371999G;
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals

    Medline Industries is recalling sterile convenience kits for various medical procedures due to potential open or weak seals on breather pouches used in product packaging.

    Product
    Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline sterile convenience kits recalled for weak breather pouch seals

    Medline is recalling two models of sterile convenience kits (PAIN PACK and PAIN TRIAL PACK) due to potential open or weak seals on breather pouches used in the packaging.

    Product
    Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Number: DYNJ67577A; 2) PAIN TRIAL PACK, Model Number: DYNJ67576A;
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline Sterile Ophthalmic Convenience Kits Recalled for Weak Breather Pouches

    Medline Industries is recalling select sterile ophthalmic convenience kits due to potential open or weak seals on breather pouches used for packaging. The kits are used for various eye procedures.

    Product
    Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Model Number: DYNJ41097A; 2) PK EYE, Model Number: DYNJ60631B; 3) CATARACT PACK, Model Number: DYNJ80316A; 4) BASIC EYE PACK, Model Number: DYNJ63707C; 5) EYE PACK WITH ACCESSORY PACK, Model Number:
    Category
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    0 states
  • ModerateFDA (Devices)··2025-04-23

    Medline Hernia Repair Convenience Kit Recalls Due to Weak Seals

    Medline is recalling Hernia Repair Tote convenience kits (Model DYNJ908337C) because purchased breather pouches used for packaging may have open or weak seals, which could compromise product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE, Model Number: DYNJ908337C
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2025-04-23

    Medline Convenience Kits Recalled for Potentially Weak Breather Pouch Seals

    Medline Industries is recalling select sterile convenience kits with Model Number MNS12590 due to potential open or weak seals on breather pouches used in packaging. The affected lot is 24IBH166.

    Product
    Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number: MNS12590
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline Sterile Convenience Kits Recalled for Breather Pouch Sealing Defect

    Medline Industries has recalled five sterile convenience kits for various neurosurgical and implant procedures due to potential open or weak seals on breather pouches used in packaging. The defect could compromise sterility of the devices.

    Product
    Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50629M; 4) SHUNT PACK, Model Number: DYNJ40040C; 5) STIM IMPLANT PACK, Model N
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline Convenience Kits Recalled for Potential Breather Pouch Seal Defects

    Medline is recalling select IV convenience kits due to potential open or weak seals on breather pouches used for packaging. The defective seals may compromise sterility of the medical devices.

    Product
    Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline sterile surgical convenience kits with potentially weak seals

    Medline Industries is recalling 33 models of sterile surgical convenience kits due to potential open or weak seals on breather pouches used for packaging. The defect may compromise sterility of the kits.

    Product
    Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ34160D; 4) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 5) PLASTIC PACK, Mo
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline sterile convenience kits recalled for potential weak breather pouch seals

    Medline Industries is recalling ten models of sterile convenience kits used for various medical procedures due to potential open or weak seals on breather pouches. The seal failure could compromise sterility of the kits.

    Product
    Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303; 4) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline Rhinoplasty Pack kits recalled for potential breather pouch seal failures

    Medline is recalling Rhinoplasty Pack convenience kits (Model DYNJ27333F) due to potential open or weak seals on breather pouches used to package the sterile kits.

    Product
    Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, Model Number: DYNJ27333F
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline Convenience Kits Recalled for Potential Weak Seals

    Medline Industries is recalling select sterile convenience kits due to a potential for open or weak seals on the breather pouches used for packaging. The affected kits are distributed nationwide and in Canada, Mexico, Panama, and the Virgin Islands.

    Product
    Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2025-04-23

    Medline Sterile Convenience Kits Recalled for Defective Breather Pouches

    Medline Industries is recalling select sterile convenience kits due to the potential for open or weak seals on breather pouches used in packaging. Affected units were distributed nationwide and internationally.

    Product
    Refer to RES
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2025-04-23

    Medline Convenience Kit Drape Packs Recalled for Weak Seal Risk

    Medline Industries is recalling UNIVERSAL DRAPE PACK convenience kits because their breather pouches may have open or weak seals, potentially compromising sterility of the packaged kits.

    Product
    Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PACK, Model Number: DYNJCD0239
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2025-04-23

    Medline Convenience Kits Recalled for Potentially Open Breather Pouches

    Medline Industries is recalling 706 units of various sterile convenience kits used for gynecological and other procedures due to potential open or weak seals on breather pouches. The packaging defect could affect product sterility.

    Product
    Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model Number: DYNJ69733; 2) NHS - LAP BOWEL GNG, Model Number: DYNJ39904A; 3) LAPAROSCOPY GYN SURGERY PA, Model Number: DYNJ64651A; 4) GYNE - LITHOTOMY MAJOR-LF, Model Number: DYNJ49250F; 5) ENS. GYNE
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2025-04-23

    Medline Convenience Kit Skin Lesion Set Potential Seal Defect

    Medline is recalling its Skin Lesion Set convenience kits due to potential open or weak seals on breather pouches used for packaging. The compromised seals may affect the sterility of the kits.

    Product
    Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Model Number: MNS6270
    Category
    Distribution
    0 states