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 CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25EDA675; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25CDA718; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 25BDA328; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 24KDB408; Medline Kit Number/SKU CDS983493N: UDI/DI each 10198459000218, UDI/DI case 40198459000219, Lot Number: 24KDA607; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23HMH658; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23GMD341; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23EMB793; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23CMG372; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 23BMI499; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22JMF967; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22EMC648; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 22CMD889; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24EMH897; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24DMF264; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24BMJ904; Medline Kit Number/SKU DYNJ02476O: UDI/DI each 10195327119478, UDI/DI case 40195327119479, Lot Number: 24AMH650; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23IME074; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23IMA416; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23EME302; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23DMH071; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23CMH752; Medline Kit Number/SKU DYNJ0426069N: UDI/DI each 10195327371319, UDI/DI case 40195327371310, Lot Number: 23LME133; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25LMB574; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25IMG534; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25EMJ878; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25DME997; Medline Kit Number/SKU DYNJ0426069Q: UDI/DI each 10198459311321, UDI/DI case 40198459311322, Lot Number: 25CMI768; Medline Kit Number/SKU DYNJ0429303L: UDI/DI each 10195327587260, UDI/DI case 40195327587261, Lot Number: 24HMH265; Medline Kit Number/SKU DYNJ0753948J: UDI/DI each 10193489895896, UDI/DI case 40193489895897, Lot Number: 21KMD078; Medline Kit Number/SKU DYNJ0753948J: UDI/DI each 10193489895896, UDI/DI case 40193489895897, Lot Number: 21HME198; Medline Kit Number/SKU DYNJ0753948J: UDI/DI each 10193489895896, UDI/DI case 40193489895897, Lot Number: 21FMD014; Medline Kit Number/SKU DYNJ0785741K: UDI/DI each 10193489603576, UDI/DI case 40193489603577, Lot Number: 21CKA430; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23JDA179; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23HDC666; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23FDB421; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23EDA191; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23CDC020; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23BDA963; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23ADB394; Medline Kit Number/SKU DYNJ0843063K: UDI/DI each 10195327286460, UDI/DI case 40195327286461, Lot Number: 23LDA280; Medline Kit Number/SKU DYNJ0991320K: UDI/DI each 10193489925388, UDI/DI case 40193489925389, Lot Number: 21ILA211; Medline Kit Number/SKU DYNJ0991320K: UDI/DI each 10193489925388, UDI/DI case 40193489925389, Lot Number: 21HLA920; Medline Kit Number/SKU DYNJ0991320K: UDI/DI each 10193489925388, UDI/DI case 40193489925389, Lot Number: 21HLA656; Medline Kit Number/SKU DYNJ0991320K: UDI/DI each 10193489925388, UDI/DI case 40193489925389, Lot Number: 21GLA243; Medline Kit Number/SKU DYNJ0991320M: UDI/DI each 10195327632458, UDI/DI case 40195327632459, Lot Number: 24IMH942; Medline Kit Number/SKU DYNJ0991320M: UDI/DI each 10195327632458, UDI/DI case 40195327632459, Lot Number: 24IMB140; Medline Kit Number/SKU DYNJ0991320M: UDI/DI each 10195327632458, UDI/DI case 40195327632459, Lot Number: 24GMB047; Medline Kit Number/SKU DYNJ0991320M: UDI/DI each 10195327632458, UDI/DI case 40195327632459, Lot Number: 24EMG280; Medline Kit Number/SKU DYNJ19521Q: UDI/DI each 10195327318079, UDI/DI case 40195327318070, Lot Number: 23BMB103; Medline Kit Number/SKU DYNJ19521Q: UDI/DI each 10195327318079, UDI/DI case 40195327318070, Lot Number: 25BMG556; Medline Kit Number/SKU DYNJ34623C: UDI/DI each 10889942745807, UDI/DI case 40889942745808, Lot Number: 23CBT880; Medline Kit Number/SKU DYNJ34623C: UDI/DI each 10889942745807, UDI/DI case 40889942745808, Lot Number: 22KBW690; Medline Kit Number/SKU DYNJ34623C: UDI/DI each 10889942745807, UDI/DI case 40889942745808, Lot Number: 21LBG909; Medline Kit Number/SKU DYNJ35305G: UDI/DI each 10195327070328, UDI/DI case 40195327070329, Lot Number: 23AMB303; Medline Kit Number/SKU DYNJ37547D: UDI/DI each 10889942945993, UDI/DI case 40889942945994, Lot Number: 21DDB912; Medline Kit Number/SKU DYNJ37547D: UDI/DI each 10889942945993, UDI/DI case 40889942945994, Lot Number: 21CDB910; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23JBY647; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23HBX192; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23GBC541; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23DBD185; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23CBP552; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23ABG640; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 22JBW980; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 22HBY401; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 22GBG635; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 22EBL969; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 22CBX216; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 22ABL872; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 21KBK659; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 21IBR941; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 21FBG655; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 21DBG029; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 21CBJ871; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 26CBE134; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 26ABM247; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25KBF571; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25IBS828; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25HBF128; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25GBD444; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25EBN746; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25DBU598; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 25BBP703; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 24LBL146; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 24HBR568; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 24GBW861; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 24FBL120; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 24EBD749; Medline Kit Number/SKU DYNJ40406A: UDI/DI each 10889942215904, UDI/DI case 40889942215905, Lot Number: 23LBI152; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 23JMA313; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 23HMH325; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 23GMA570; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 23EMI670; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 23DMC678; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 23CMB630; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 22LMF935; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 22HMF705; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 22FMD171; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 22FMD415; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 22EMB584; Medline Kit Number/SKU DYNJ40645C: UDI/DI each 10195327107802, UDI/DI case 40195327107803, Lot Number: 22DMF559; Medline Kit Number/SKU DYNJ40648G: UDI/DI each 10195327106997, UDI/DI case 40195327106998, Lot Number: 23DMH298; Medline Kit Number/SKU DYNJ40648G: UDI/DI each 10195327106997, UDI/DI case 40195327106998, Lot Number: 22KMH672; Medline Kit Number/SKU DYNJ40648G: UDI/DI each 10195327106997, UDI/DI case 40195327106998, Lot Number: 22GMD348; Medline Kit Number/SKU DYNJ40648G: UDI/DI each 10195327106997, UDI/DI case 40195327106998, Lot Number: 22FMD240; Medline Kit Number/SKU DYNJ40648G: UDI/DI each 10195327106997, UDI/DI case 40195327106998, Lot Number: 22EME295; Medline Kit Number/SKU DYNJ40648G: UDI/DI each 10195327106997, UDI/DI case 40195327106998, Lot Number: 22DMG577; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 23HBR726; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 23FBG834; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 23CBL006; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 22IBL408; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 22HBY173; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 22EBF344; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 22ABB710; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 21LBR187; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 21KBE554; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 21HBQ602; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 21HBQ631; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 21GBJ642; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 21CBS316; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 21BBN842; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 25EBR511; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 25BBU313; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 24IBF115; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 24GBX974; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 24FBR318; Medline Kit Number/SKU DYNJ50808A: UDI/DI each 10889942368105, UDI/DI case 40889942368106, Lot Number: 24ABP408; Medline Kit Number/SKU DYNJ52062: UDI/DI each 10889942235742, UDI/DI case 40889942235743, Lot Number: 21LBU391; Medline Kit Number/SKU DYNJ52062: UDI/DI each 10889942235742, UDI/DI case 40889942235743, Lot Number: 21VBD187; Medline Kit Number/SKU DYNJ52116B: UDI/DI each 10193489755589, UDI/DI case 40193489755580, Lot Number: 23JMB108; Medline Kit Number/SKU DYNJ52116B: UDI/DI each 10193489755589, UDI/DI case 40193489755580, Lot Number: 23EMJ664; Medline Kit Number/SKU DYNJ52116B: UDI/DI each 10193489755589, UDI/DI case 40193489755580, Lot Number: 23CMC992; Medline Kit Number/SKU DYNJ52116B: UDI/DI each 10193489755589, UDI/DI case 40193489755580, Lot Number: 22LMF460; Medline Kit Number/SKU DYNJ52116B: UDI/DI each 10193489755589, UDI/DI case 40193489755580, Lot Number: 22FMD641; Medline Kit Number/SKU DYNJ52116B: UDI/DI each 10193489755589, UDI/DI case 40193489755580, Lot Number: 22ABG291; Medline Kit Number/SKU DYNJ52116B: UDI/DI each 10193489755589, UDI/DI case 40193489755580, Lot Number: 21KBF791; Medline Kit Number/SKU DYNJ52116B: UDI/DI each 10193489755589, UDI/DI case 40193489755580, Lot Number: 21HBT589; Medline Kit Number/SKU DYNJ52116B: UDI/DI each 10193489755589, UDI/DI case 40193489755580, Lot Number: 21DBJ867; Medline Kit Number/SKU DYNJ52116B: UDI/DI each 10193489755589, UDI/DI case 40193489755580, Lot Number: 21CBA789; Medline Kit Number/SKU DYNJ52116B: UDI/DI each 10193489755589, UDI/DI case 40193489755580, Lot Number: 24FMF952; Medline Kit Number/SKU DYNJ52116B: UDI/DI each 10193489755589, UDI/DI case 40193489755580, Lot Number: 24BMJ713; Medline Kit Number/SKU DYNJ52116C: UDI/DI each 10198459270352, UDI/DI case 40198459270353, Lot Number: 25LMD153; Medline Kit Number/SKU DYNJ52116C: UDI/DI each 10198459270352, UDI/DI case 40198459270353, Lot Number: 25KMH925; Medline Kit Number/SKU DYNJ52116C: UDI/DI each 10198459270352, UDI/DI case 40198459270353, Lot Number: 25BMD068; Medline Kit Number/SKU DYNJ54719C: UDI/DI each 10193489433449, UDI/DI case 40193489433440, Lot Number: 21CBH091; Medline Kit Number/SKU DYNJ54719C: UDI/DI each 10193489433449, UDI/DI case 40193489433440, Lot Number: 21ABM862; Medline Kit Number/SKU DYNJ54719D: UDI/DI each 10193489885293, UDI/DI case 40193489885294, Lot Number: 21HBE730; Medline Kit Number/SKU DYNJ54719D: UDI/DI each 10193489885293, UDI/DI case 40193489885294, Lot Number: 21FBO645; Medline Kit Number/SKU DYNJ56917I: UDI/DI each 10193489375206, UDI/DI case 40193489375207, Lot Number: 21GDB034; Medline Kit Number/SKU DYNJ56917I: UDI/DI each 10193489375206, UDI/DI case 40193489375207, Lot Number: 21FDC469; Medline Kit Number/SKU DYNJ56917I: UDI/DI each 10193489375206, UDI/DI case 40193489375207, Lot Number: 21EDC231; Medline Kit Number/SKU DYNJ56917I: UDI/DI each 10193489375206, UDI/DI case 40193489375207, Lot Number: 21ADA830; Medline Kit Number/SKU DYNJ56917J: UDI/DI each 10193489991994, UDI/DI case 40193489991995, Lot Number: 22KDA276; Medline Kit Number/SKU DYNJ56917J: UDI/DI each 10193489991994, UDI/DI case 40193489991995, Lot Number: 22JDA493; Medline Kit Number/SKU DYNJ56917J: UDI/DI each 10193489991994, UDI/DI case 40193489991995, Lot Number: 22FDB151; Medline Kit Number/SKU DYNJ56917J: UDI/DI each 10193489991994, UDI/DI case 40193489991995, Lot Number: 22EDB139; Medline Kit Number/SKU DYNJ56917J: UDI/DI each 10193489991994, UDI/DI case 40193489991995, Lot Number: 22DDA699; Medline Kit Number/SKU DYNJ56917J: UDI/DI each 10193489991994, UDI/DI case 40193489991995, Lot Number: 22BDA826; Medline Kit Number/SKU DYNJ56917J: UDI/DI each 10193489991994, UDI/DI case 40193489991995, Lot Number: 21KDB492; Medline Kit Number/SKU DYNJ56917J: UDI/DI each 10193489991994, UDI/DI case 40193489991995, Lot Number: 21IDB626; Medline Kit Number/SKU DYNJ56917K: UDI/DI each 10195327322571, UDI/DI case 40195327322572, Lot Number: 23EDC310; Medline Kit Number/SKU DYNJ56917K: UDI/DI each 10195327322571, UDI/DI case 40195327322572, Lot Number: 23DDA529; Medline Kit Number/SKU DYNJ56917K: UDI/DI each 10195327322571, UDI/DI case 40195327322572, Lot Number: 23BDC220; Medline Kit Number/SKU DYNJ56917K: UDI/DI each 10195327322571, UDI/DI case 40195327322572, Lot Number: 23ADB232; Medline Kit Number/SKU DYNJ56917L: UDI/DI each 10195327466855, UDI/DI case 40195327466856, Lot Number: 23KDB950; Medline Kit Number/SKU DYNJ56917L: UDI/DI each 10195327466855, UDI/DI case 40195327466856, Lot Number: 23JDB895; Medline Kit Number/SKU DYNJ56917L: UDI/DI each 10195327466855, UDI/DI case 40195327466856, Lot Number: 24BDB140; Medline Kit Number/SKU DYNJ56917N: UDI/DI each 10198459140488, UDI/DI case 40198459140489, Lot Number: 25IMB406; Medline Kit Number/SKU DYNJ56917N: UDI/DI each 10198459140488, UDI/DI case 40198459140489, Lot Number: 25EMA512; Medline Kit Number/SKU DYNJ56917N: UDI/DI each 10198459140488, UDI/DI case 40198459140489, Lot Number: 25DMG834; Medline Kit Number/SKU DYNJ56917N: UDI/DI each 10198459140488, UDI/DI case 40198459140489, Lot Number: 25CMC310; Medline Kit Number/SKU DYNJ56917N: UDI/DI each 10198459140488, UDI/DI case 40198459140489, Lot Number: 25BMC774; Medline Kit Number/SKU DYNJ56917N: UDI/DI each 10198459140488, UDI/DI case 40198459140489, Lot Number: 25BMC034; Medline Kit Number/SKU DYNJ56917N: UDI/DI each 10198459140488, UDI/DI case 40198459140489, Lot Number: 24JDB128; Medline Kit Number/SKU DYNJ58324A: UDI/DI each 10193489485639, UDI/DI case 40193489485630, Lot Number: 23FBS890; Medline Kit Number/SKU DYNJ58324A: UDI/DI each 10193489485639, UDI/DI case 40193489485630, Lot Number: 23DBO019; Medline Kit Number/SKU DYNJ58324A: UDI/DI each 10193489485639, UDI/DI case 40193489485630, Lot Number: 22IBG087; Medline Kit Number/SKU DYNJ58324A: UDI/DI each 10193489485639, UDI/DI case 40193489485630, Lot Number: 22BBZ926; Medline Kit Number/SKU DYNJ58324A: UDI/DI each 10193489485639, UDI/DI case 40193489485630, Lot Number: 21CBO062; Medline Kit Number/SKU DYNJ58324A: UDI/DI each 10193489485639, UDI/DI case 40193489485630, Lot Number: 21CBT626; Medline Kit Number/SKU DYNJ58324A: UDI/DI each 10193489485639, UDI/DI case 40193489485630, Lot Number: 21ABA621; Medline Kit Number/SKU DYNJ58324A: UDI/DI each 10193489485639, UDI/DI case 40193489485630, Lot Number: 25FBB275; Medline Kit Number/SKU DYNJ58324A: UDI/DI each 10193489485639, UDI/DI case 40193489485630, Lot Number: 24HBQ403; Medline Kit Number/SKU DYNJ58324A: UDI/DI each 10193489485639, UDI/DI case 40193489485630, Lot Number: 24HBC985; Medline Kit Number/SKU DYNJ58324A: UDI/DI each 10193489485639, UDI/DI case 40193489485630, Lot Number: 24FBB168; Medline Kit Number/SKU DYNJ58324A: UDI/DI each 10193489485639, UDI/DI case 40193489485630, Lot Number: 24EBK104; Medline Kit Number/SKU DYNJ58324A: UDI/DI each 10193489485639, UDI/DI case 40193489485630, Lot Number: 24CBG181; Medline Kit Number/SKU DYNJ67558A: UDI/DI each 10193489917437, UDI/DI case 40193489917438, Lot Number: 21FBF038; Medline Kit Number/SKU DYNJ67558B: UDI/DI each 10195327099053, UDI/DI case 40195327099054, Lot Number: 22OBG478; Medline Kit Number/SKU DYNJ68213: UDI/DI each 10193489816129, UDI/DI case 40193489816120, Lot Number: 22EMA482; Medline Kit Number/SKU DYNJ68213: UDI/DI each 10193489816129, UDI/DI case 40193489816120, Lot Number: 22CMI811; Medline Kit Number/SKU DYNJ68213: UDI/DI each 10193489816129, UDI/DI case 40193489816120, Lot Number: 22CMG430; Medline Kit Number/SKU DYNJ68213: UDI/DI each 10193489816129, UDI/DI case 40193489816120, Lot Number: 22AMB156; Medline Kit Number/SKU DYNJ68213: UDI/DI each 10193489816129, UDI/DI case 40193489816120, Lot Number: 21KMB789; Medline Kit Number/SKU DYNJ68213: UDI/DI each 10193489816129, UDI/DI case 40193489816120, Lot Number: 21IMG069; Medline Kit Number/SKU DYNJ68213: UDI/DI each 10193489816129, UDI/DI case 40193489816120, Lot Number: 21IMA320; Medline Kit Number/SKU DYNJ68213: UDI/DI each 10193489816129, UDI/DI case 40193489816120, Lot Number: 21GMF680; Medline Kit Number/SKU DYNJ68213: UDI/DI each 10193489816129, UDI/DI case 40193489816120, Lot Number: 21GMC469; Medline Kit Number/SKU DYNJ68213: UDI/DI each 10193489816129, UDI/DI case 40193489816120, Lot Number: 21FMB885; Medline Kit Number/SKU DYNJ68213: UDI/DI each 10193489816129, UDI/DI case 40193489816120, Lot Number: 21EME095; Medline Kit Number/SKU DYNJ68213: UDI/DI each 10193489816129, UDI/DI case 40193489816120, Lot Number: 21DMB893; Medline Kit Number/SKU DYNJ68213: UDI/DI each 10193489816129, UDI/DI case 40193489816120, Lot Number: 21BMC546; Medline Kit Number/SKU DYNJ68213D: UDI/DI each 10198459093395, UDI/DI case 40198459093396, Lot Number: 25FMB744; Medline Kit Number/SKU DYNJ68213D: UDI/DI each 10198459093395, UDI/DI case 40198459093396, Lot Number: 25DMG846; Medline Kit Number/SKU DYNJ68213D: UDI/DI each 10198459093395, UDI/DI case 40198459093396, Lot Number: 25BMB216; Medline Kit Number/SKU DYNJ68213D: UDI/DI each 10198459093395, UDI/DI case 40198459093396, Lot Number: 24KMI278; Medline Kit Number/SKU DYNJ68213D: UDI/DI each 10198459093395, UDI/DI case 40198459093396, Lot Number: 24JMG883; Medline Kit Number/SKU DYNJ68213D: UDI/DI each 10198459093395, UDI/DI case 40198459093396, Lot Number: 24JMC380; Medline Kit Number/SKU DYNJ68213G: UDI/DI each 10198459648175, UDI/DI case 40198459648176, Lot Number: 26AMA296; Medline Kit Number/SKU DYNJ68366B: UDI/DI each 10195327666330, UDI/DI case 40195327666331, Lot Number: 24EMB363; Medline Kit Number/SKU DYNJ68447: UDI/DI each 10193489447095, UDI/DI case 40193489447096, Lot Number: 21CBL485; Medline Kit Number/SKU DYNJ68447A: UDI/DI each 10193489913804, UDI/DI case 40193489913805, Lot Number: 21VBB288; Medline Kit Number/SKU DYNJ68447A: UDI/DI each 10193489913804, UDI/DI case 40193489913805, Lot Number: 21IBV467; Medline Kit Number/SKU DYNJ68447A: UDI/DI each 10193489913804, UDI/DI case 40193489913805, Lot Number: 21IBG628; Medline Kit Number/SKU DYNJ68447A: UDI/DI each 10193489913804, UDI/DI case 40193489913805, Lot Number: 21GBN769; Medline Kit Number/SKU DYNJ68447B: UDI/DI each 10195327034160, UDI/DI case 40195327034161, Lot Number: 22NBF961; Medline Kit Number/SKU DYNJ68447B: UDI/DI each 10195327034160, UDI/DI case 40195327034161, Lot Number: 22ABV162; Medline Kit Number/SKU DYNJ68447B: UDI/DI each 10195327034160, UDI/DI case 40195327034161, Lot Number: 21LBR924; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 23JBU091; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 23JBC614; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 23EBR266; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 23EBB687; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 23CBV202; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 23BBP560; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 23ABL869; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 23ABI200; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 22KBJ128; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 22IBU121; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 22HBY433; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 22GBR086; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 22GBQ113; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 22FBP609; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 22BBU834; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 25FBB994; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 25DBQ190; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 25CBN006; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 25ABQ389; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 24KBO095; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 24JBQ827; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 24IBH741; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 24HBO248; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 24GBK688; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 24GBE944; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 24FBQ277; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 24EBO557; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 24EBB354; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 24BBU070; Medline Kit Number/SKU DYNJ69824: UDI/DI each 10193489981698, UDI/DI case 40193489981699, Lot Number: 23LBT175; Medline Kit Number/SKU DYNJ81325: UDI/DI each 10195327111014, UDI/DI case 40195327111015, Lot Number: 22JBC490; Medline Kit Number/SKU DYNJ81325: UDI/DI each 10195327111014, UDI/DI case 40195327111015, Lot Number: 22GBW885; Medline Kit Number/SKU DYNJ81325: UDI/DI each 10195327111014, UDI/DI case 40195327111015, Lot Number: 22EBA478; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 23KBD697; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 23JBC513; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 23IBD507; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 23FBS833; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 23DBS310; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 23CBW627; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 23BBO729; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 22KBT451; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 22KBD178; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 24KBA572; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 24JBH042; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 24IBT346; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 24FBJ124; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 24EBN022; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 24DBL535; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 24BBS543; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 24ABN491; Medline Kit Number/SKU DYNJ81325A: UDI/DI each 10195327270360, UDI/DI case 40195327270361, Lot Number: 23LBF176; Medline Kit Number/SKU DYNJ81325B: UDI/DI each 10198459217029, UDI/DI case 40198459217020, Lot Number: 25FBD987; Medline Kit Number/SKU DYNJ81325B: UDI/DI each 10198459217029, UDI/DI case 40198459217020, Lot Number: 25EBD835; Medline Kit Number/SKU DYNJ81325B: UDI/DI each 10198459217029, UDI/DI case 40198459217020, Lot Number: 25BBE525; Medline Kit Number/SKU DYNJ81751: UDI/DI each 10195327139315, UDI/DI case 40195327139316, Lot Number: 23ABA516; Medline Kit Number/SKU DYNJ81751: UDI/DI each 10195327139315, UDI/DI case 40195327139316, Lot Number: 22JBE441; Medline Kit Number/SKU DYNJ81751: UDI/DI each 10195327139315, UDI/DI case 40195327139316, Lot Number: 22JBD573; Medline Kit Number/SKU DYNJ81751: UDI/DI each 10195327139315, UDI/DI case 40195327139316, Lot Number: 22GBX010; Medline Kit Number/SKU DYNJ81751A: UDI/DI each 10195327345112, UDI/DI case 40195327345113, Lot Number: 23JBW345; Medline Kit Number/SKU DYNJ81751A: UDI/DI each 10195327345112, UDI/DI case 40195327345113, Lot Number: 23JBG162; Medline Kit Number/SKU DYNJ81751A: UDI/DI each 10195327345112, UDI/DI case 40195327345113, Lot Number: 23FBA908; Medline Kit Number/SKU DYNJ81751A: UDI/DI each 10195327345112, UDI/DI case 40195327345113, Lot Number: 23EBW504; Medline Kit Number/SKU DYNJ81751A: UDI/DI each 10195327345112, UDI/DI case 40195327345113, Lot Number: 26ABU708; Medline Kit Number/SKU DYNJ81751A: UDI/DI each 10195327345112, UDI/DI case 40195327345113, Lot Number: 25LBM684; Medline Kit Number/SKU DYNJ81751A: UDI/DI each 10195327345112, UDI/DI case 40195327345113, Lot Number: 25KBQ995; Medline Kit Number/SKU DYNJ81751A: UDI/DI e
✅ 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.