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.
Issued by
FDA
Distribution: Worldwide distribution.
Lot/Code Info: Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 22BBJ540; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21LBM539; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21IBX286; Medline Kit Number/SKU DYNJ40566C: UDI/DI each10889942469659, UDI/DI case 40889942469650, Lot Number: 21HBM832; Medline Kit Number/SKU DYNJ47491F: UDI/DI each10193489586725, UDI/DI case 40193489586726, Lot Number: 21KMD114; Medline Kit Number/SKU DYNJ58274: UDI/DI each10889942840724, UDI/DI case 40889942840725, Lot Number: 22FMI371; Medline Kit Number/SKU DYNJ58274: UDI/DI each10889942840724, UDI/DI case 40889942840725, Lot Number: 21IMD775; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23JBD782; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23HBY508; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23GBQ615; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23EBR984; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23EBD017; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 23BBO048; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 22JBI096; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 22FBA057; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 22CBA050; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21IBG464; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21GBJ471; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21EBA373; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21DBG514; Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721, UDI/DI case 40889942841722, Lot Number: 21ABD741; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23IBQ007; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23GBM279; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23EBT579; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23DBT199; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23CBP725; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23CBH452; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23ABR478; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22JBU430; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22IBM433; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22GBW568; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22EBG751; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22DBT428; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22DBE203; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 22NBF066; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 21KBZ291; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 21IBL547; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 21FBQ973; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 21DBI879; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 26ABQ626; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25KBI185; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25JBK909; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25HBN871; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25FBI730; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25DBR613; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 25BBP811; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 24KBT890; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 24HBT785; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 24HBH475; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 24FBP481; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 24DBH874; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 24CBG680; Medline Kit Number/SKU DYNJS3016: UDI/DI each10884389201640, UDI/DI case 40884389201641, Lot Number: 23LBI949.
✅ What Should You Do?
1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.