Medline Industries, LP — Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJ
⚠️ 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.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- March 19, 2026
Worldwide distribution.
What's affected?
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58274; 4. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJ58344; 5. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU DYNJS3016.
- Lot code
- 22BBJ540
Additional details
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 I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 7004 kits.
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