Recall archive / FDA device enforcement

Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SIN... — FDA record Z-2021-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 19, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.
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.
Classification: Class II
Recalling firm: Medline Industries, LP
Quantity: 486946 kits
Agency-reported status: Ongoing
Source record identifier: Z-2021-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Medline Kit Number/SKU AM310B: UDI/DI each 10193489242126, UDI/DI case 40193489242127, Lot Number: 20XBG776; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23JBF547; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23GBK604; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBO915; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBD581; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABP476; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABD648; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22LBE888; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22HBL188; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22HBF976; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22FBN678; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22DBK641; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22BBU367; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22ABD373; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21JBC146; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21IBA072; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21FBN768; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21FBB075; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21EBI490; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24CBU365; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24BBE020; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24ABJ712; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23LBM852; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 26BBM084; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25LBS053; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25KBL217; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25JBA568; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25GBM602; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25FBB309; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25CBN201; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25CBI539; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24KBJ971; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24IBV278; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24IBR437; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24HBM092; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24FBP548; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 23GDA870; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 23FDA168; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 23ADB195; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 22EDB625; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 22CDC141; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 21JDB377; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 21IDA882; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 21HDB855; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 26BDA373; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 25HDA036; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 25EDA147; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 25DDB518; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24KDB412; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24JDC373; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24FDA893; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24EDB481; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24BDB518; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 23LDB380; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 23CME129; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22LME628; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22KMG745; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22IMD591; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22GMH942; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22GMB473; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22EMB645; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22AMA586; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21KMA503; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21HMF136; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21GMC528; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21FMD781; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21FMB792; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21EME021; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23GBM193; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23FBN485; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23EBP721; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23CBX462; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23ABM479; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 22JBW425; Medline Kit Number/SKU CDS982020S: UDI/DI each 10195327657468, UDI/DI case 40195327657469, Lot Number: 25AMI029; Medline Kit Number/SKU CDS982020S: UDI/DI each 10195327657468, UDI/DI case 40195327657469, Lot Number: 24LMH803; Medline Kit Number/SKU CDS982020S: UDI/DI each 10195327657468, UDI/DI case 40195327657469, Lot Number: 24KMG612; Medline Kit Number/SKU CDS982020S: UDI/DI each 10195327657468, UDI/DI case 40195327657469, Lot Number: 24IMI778; Medline Kit Number/SKU CDS982020T: UDI/DI each 10198459385490, UDI/DI case 40198459385491, Lot Number: 26AMG222; Medline Kit Number/SKU CDS982020T: UDI/DI each 10198459385490, UDI/DI case 40198459385491, Lot Number: 25KMF284; Medline Kit Number/SKU CDS982596L: UDI/DI each 10193489712209, UDI/DI case 40193489712200, Lot Number: 21BKA098; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23KMA344; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23HMB694; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23GMF880; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23FMI753; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23FMF062; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23AMF870; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22LMD446; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22IMD630; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22GMC294; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22EMG730; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22CMG908; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22BME437; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22AMB333; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 25DMD274; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 25BMB788; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 25AMH330; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24JMG325; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24GMF217; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24EMB761; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24DMA557; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24CMH849; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24BMC117; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23JBN252; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23IBM139; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23FBC217; Medline Kit Number/SKU ...

Label field

Details supplied by the agency

Lot, code or applicability

Medline Kit Number/SKU AM310B: UDI/DI each 10193489242126, UDI/DI case 40193489242127, Lot Number: 20XBG776; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23JBF547; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23GBK604; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBO915; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBD581; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABP476; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABD648; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22LBE888; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22HBL188; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22HBF976; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22FBN678; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22DBK641; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22BBU367; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22ABD373; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21JBC146; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21IBA072; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21FBN768; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21FBB075; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21EBI490; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24CBU365; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24BBE020; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24ABJ712; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23LBM852; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 26BBM084; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25LBS053; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25KBL217; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25JBA568; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25GBM602; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25FBB309; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25CBN201; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25CBI539; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24KBJ971; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24IBV278; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24IBR437; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24HBM092; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24FBP548; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 23GDA870; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 23FDA168; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 23ADB195; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 22EDB625; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 22CDC141; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 21JDB377; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 21IDA882; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 21HDB855; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 26BDA373; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 25HDA036; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 25EDA147; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 25DDB518; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24KDB412; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24JDC373; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24FDA893; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24EDB481; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24BDB518; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 23LDB380; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 23CME129; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22LME628; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22KMG745; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22IMD591; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22GMH942; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22GMB473; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22EMB645; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22AMA586; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21KMA503; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21HMF136; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21GMC528; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21FMD781; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21FMB792; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21EME021; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23GBM193; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23FBN485; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23EBP721; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23CBX462; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23ABM479; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 22JBW425; Medline Kit Number/SKU CDS982020S: UDI/DI each 10195327657468, UDI/DI case 40195327657469, Lot Number: 25AMI029; Medline Kit Number/SKU CDS982020S: UDI/DI each 10195327657468, UDI/DI case 40195327657469, Lot Number: 24LMH803; Medline Kit Number/SKU CDS982020S: UDI/DI each 10195327657468, UDI/DI case 40195327657469, Lot Number: 24KMG612; Medline Kit Number/SKU CDS982020S: UDI/DI each 10195327657468, UDI/DI case 40195327657469, Lot Number: 24IMI778; Medline Kit Number/SKU CDS982020T: UDI/DI each 10198459385490, UDI/DI case 40198459385491, Lot Number: 26AMG222; Medline Kit Number/SKU CDS982020T: UDI/DI each 10198459385490, UDI/DI case 40198459385491, Lot Number: 25KMF284; Medline Kit Number/SKU CDS982596L: UDI/DI each 10193489712209, UDI/DI case 40193489712200, Lot Number: 21BKA098; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23KMA344; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23HMB694; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23GMF880; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23FMI753; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23FMF062; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23AMF870; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22LMD446; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22IMD630; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22GMC294; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22EMG730; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22CMG908; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22BME437; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22AMB333; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 25DMD274; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 25BMB788; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 25AMH330; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24JMG325; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24GMF217; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24EMB761; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24DMA557; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24CMH849; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24BMC117; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23JBN252; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23IBM139; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23FBC217; Medline Kit Number/SKU ...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: May 6, 2026
Recall initiation date: Mar 19, 2026
Center classification date: Apr 30, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records