BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450B; 5. ORAL SURGERY PACK RFID, Medline Kit Number/SKU DYNJ66450C; 6. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450D; 7. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450F; 8. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450G.

    Recall: Z-2019-2026 · Reported May 6, 2026

    Enforcement

    Recall Number
    Z-2019-2026
    Event ID
    98664
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 6, 2026
    Initiation Date
    March 19, 2026
    Classification Date
    April 30, 2026
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450B; 5. ORAL SURGERY PACK RFID, Medline Kit Number/SKU DYNJ66450C; 6. ORAL SURGERY PACK, Medline Kit Number/SKU DYNJ66450D; 7. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450F; 8. ORAL SURGERY PACK RFID-V2, Medline Kit Number/SKU DYNJ66450G.

    Reason

    During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

    Code Info

    Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23JMB165; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23CMH103; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23BMH200; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23BMB495; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 22KMH108; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 22KME285; Medline Kit Number/SKU DYNJ0045920D: UDI/DI each 10195327267407, UDI/DI case 40195327267408, Lot Number: 23KMJ648; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 26BME013; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25JMC725; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25IMA571; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25HMC497; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25FMG199; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25EMB523; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25DMF918; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 25CMH298; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24LMA598; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24JMH963; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24IMC899; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24IMD398; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24EME289; Medline Kit Number/SKU DYNJ0045920F: UDI/DI each 10195327643713, UDI/DI case 40195327643714, Lot Number: 24CMG724; Medline Kit Number/SKU DYNJ0660040S: UDI/DI each 10198459674907, UDI/DI case 40198459674908, Lot Number: 26BMD088; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23JBW720; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23EBR729; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23DBC424; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23CBD133; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23BBA368; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 22LBG835; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 22KBV773; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 22IBB948; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 24BBP259; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 24ABS878; Medline Kit Number/SKU DYNJ66450B: UDI/DI each 10195327191689, UDI/DI case 40195327191680, Lot Number: 23LBH114; Medline Kit Number/SKU DYNJ66450C: UDI/DI each 10195327671136, UDI/DI case 40195327671137, Lot Number: 24GBC544; Medline Kit Number/SKU DYNJ66450C: UDI/DI each 10195327671136, UDI/DI case 40195327671137, Lot Number: 24FBL453; Medline Kit Number/SKU DYNJ66450C: UDI/DI each 10195327671136, UDI/DI case 40195327671137, Lot Number: 24EBH347; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 25DBC120; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 25CBF213; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 24KBU249; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 24IBQ393; Medline Kit Number/SKU DYNJ66450D: UDI/DI each 10198459059216, UDI/DI case 40198459059217, Lot Number: 24HBN580; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25JBA224; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25HBQ050; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25GBN753; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25GBJ601; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25FBQ773; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25FBB129; Medline Kit Number/SKU DYNJ66450F: UDI/DI each 10198459334146, UDI/DI case 40198459334147, Lot Number: 25FBE608; Medline Kit Number/SKU DYNJ66450G: UDI/DI each 10198459568817, UDI/DI case 40198459568818, Lot Number: 25LBS231; Medline Kit Number/SKU DYNJ66450G: UDI/DI each 10198459568817, UDI/DI case 40198459568818, Lot Number: 25LBF336; Medline Kit Number/SKU DYNJ66450G: UDI/DI each 10198459568817, UDI/DI case 40198459568818, Lot Number: 25LBC263; Medline Kit Number/SKU DYNJ66450G: UDI/DI each 10198459568817, UDI/DI case 40198459568818, Lot Number: 25JBL075.

    Distribution

    Worldwide distribution.

    Quantity

    2228 kits