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Medline Industries, LP: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M

Medical DevicesSource: FDA (device) · Date: 2026-05-06

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medline Industries, LP
Product
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ENDOSCOPY-LF, Medline Kit Number/SKU DYNJ22890M; 2. ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ40645B; 3. ENT PK 1008847, Medline Kit Number/SKU DYNJ42319C; 4. ENDO SINUS PACK, Medline Kit Number/SKU DYNJ66449; 5. ENT, Medline Kit Number/SKU DYNJ900282I; 6. SEPTO/ENDO, Medline Kit Number/SKU DYNJ902831D; 7. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ906630.
Reason / hazard
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
Status
Ongoing
Distribution / sold at
Worldwide distribution.
Recall initiated
2026-03-19
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.
Product quantity
2153 kits
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
98664
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