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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.

Class II
Recalling firm
Medline Industries, LP
Reason for recall
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.
Affected products (lot / model / serial)
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 eac
Units affected
2228 kits
Distribution pattern
Worldwide distribution.
Firm location
Northfield, IL, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Devices
Status
Ongoing
Recall number
Z-2019-2026
Recall initiated
March 19, 2026
FDA classification date
April 30, 2026
FDA report date
May 6, 2026
FDA event ID
98664
Last updated on HTM Vibe
July 24, 2026
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