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 DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 23DBM600; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 22JBM081; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 22ABJ346; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21KBO873; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21KBO877; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21JBX107; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21BBE213; Medline Kit Number/SKU DYNJ22890M: UDI/DI each 10193489766486, UDI/DI case 40193489766487, Lot Number: 21BBB024; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 22AMD386; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21LMC822; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21JMF409; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21IMC184; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21GMB555; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21EMD626; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21CMC668; Medline Kit Number/SKU DYNJ40645B: UDI/DI each 10193489292183, UDI/DI case 40193489292184, Lot Number: 21AMB081; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 23FMD067; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 23EMB306; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 23CMD967; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22KMB384; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22OBB494; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22BBT747; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 22ABA711; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21LBG900; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21KBD492; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21EBS624; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21CBY739; Medline Kit Number/SKU DYNJ42319C: UDI/DI each 10193489219722, UDI/DI case 40193489219723, Lot Number: 21ABL492; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 22KBD211; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 22JBX995; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 22JBL500; Medline Kit Number/SKU DYNJ66449: UDI/DI each 10193489356113, UDI/DI case 40193489356114, Lot Number: 24CBB115; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 22ABB463; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 22ABB461; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 21KBT464; Medline Kit Number/SKU DYNJ900282I: UDI/DI each 10193489798616, UDI/DI case 40193489798617, Lot Number: 21KBP591; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 23EBS895; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 23CBU007; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 23ABE854; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22LBE910; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22JBP701; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22FBV579; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22BBZ713; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 22BBZ714; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21LBD683; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21IBM004; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21FBJ190; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21EBE932; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21DBA613; Medline Kit Number/SKU DYNJ902831D: UDI/DI each 10193489231670, UDI/DI case 40193489231671, Lot Number: 21CBI323; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 22FBM378; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 22EBE987; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 22OBI162; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 21KBF463; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 21IBU411; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 21GBJ251; Medline Kit Number/SKU DYNJ906630: UDI/DI each 10193489798852, UDI/DI case 40193489798853, Lot Number: 21DBU812.
✅ 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.