Medline medical procedure kits recall: Endotoxin
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A; 4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B; 5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A; 6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A; 7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478; 8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025; 9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030; 10. NEURO, Medline Kit Number/SKU DYNJ902935K; 11. OCULAR, Medline Kit Number/SKU DYNJ909065; 12. OCULAR, Medline Kit Number/SKU DYNJ909065A.
Why was Medline medical procedure kits recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Medline Kit Number/SKU DYNJ48725A: UDI/DI each 10193489853896, UDI/DI case 40193489853897, Lot Number: 24IMG757; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 22FME241; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 22DMC340; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21JMC829; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21IMC497; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21HMD139; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21GME747; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21FMA440; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21DBU602; Medline Kit Number/SKU DYNJ64138B: UDI/DI each 10193489355284, UDI/DI case 40193489355285, Lot Number: 21CBJ936; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23IBC227; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23FBA458; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23DBC239; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 23ABI841; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBP260; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBO842; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22IBN801; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 22GBL794; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24HBB998; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24DBQ664; Medline Kit Number/SKU DYNJ64572A: UDI/DI each 10195327112554, UDI/DI case 40195327112555, Lot Number: 24CBQ260; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 26ABC645; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25LBB014; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25JBM975; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25HBN493; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25GBM010; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25FBJ206; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25CBN002; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25ABF979; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 25ABA086; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 24JBE583; Medline Kit Number/SKU DYNJ64572B: UDI/DI each 10198459131752, UDI/DI case 40198459131753, Lot Number: 24JBG667; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25KBQ749; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25JBF743; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 25IBA573; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24IBO985; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24IBB916; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24GBY148; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 24EBO714; Medline Kit Number/SKU DYNJ67284A: UDI/DI each 10195327575731, UDI/DI case 40195327575732, Lot Number: 23LBH320; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23KBO017; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23JBA275; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23GBK387; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23CBD302; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 26ABF562; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 25GBF664; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 25EBB838; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 25BBQ021; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24LBB454; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24JBE139; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24GBI010; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24FBR965; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24DBQ797; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 24BBH448; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23LBL498; Medline Kit Number/SKU DYNJ81411A: UDI/DI each 10195327320836, UDI/DI case 40195327320837, Lot Number: 23KBX879; Medline Kit Number/SKU DYNJ84478: UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 23IBE948; Medline Kit Number/SKU DYNJ84478: UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 23FBB413; Medline Kit Number/SKU DYNJ84478: UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 24ABN367; Medline Kit Number/SKU DYNJ84478: UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 24ABA089; Medline Kit Number/SKU DYNJ84478: UDI/DI each 10195327370107, UDI/DI case 40195327370108, Lot Number: 23KBU302; Medline Kit Number/SKU DYNJ85025: UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 25LBL874; Medline Kit Number/SKU DYNJ85025: UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 25HBD880; Medline Kit Number/SKU DYNJ85025: UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 25EBI919; Medline Kit Number/SKU DYNJ85025: UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 24LBG184; Medline Kit Number/SKU DYNJ85025: UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 24LBF578; Medline Kit Number/SKU DYNJ85025: UDI/DI each 10195327447564, UDI/DI case 40195327447565, Lot Number: 24JBS764; Medline Kit Number/SKU DYNJ89030: UDI/DI each 10198459229725, UDI/DI case 40198459229726, Lot Number: 25JBH439; Medline Kit Number/SKU DYNJ89030: UDI/DI each 10198459229725, UDI/DI case 40198459229726, Lot Number: 25ABP922; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23IBW005; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23IBG214; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23FBP153; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23FBN621; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23EBW204; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23EBE141; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 24DBP594; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 24BBB058; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 24BBB100; Medline Kit Number/SKU DYNJ902935K: UDI/DI each 10195327370442, UDI/DI case 40195327370443, Lot Number: 23LBE522; Medline Kit Number/SKU DYNJ909065: UDI/DI each 10195327260019, UDI/DI case 40195327260010, Lot Number: 23CMB048; Medline Kit Number/SKU DYNJ909065: UDI/DI each 10195327260019, UDI/DI case 40195327260010, Lot Number: 23CMA495; Medline Kit Number/SKU DYNJ909065: UDI/DI each 10195327260019, UDI/DI case 40195327260010, Lot Number: 22LMD749; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 23HMI877; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 23HMH413; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 25GMJ496; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 25DMD357; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 25AMJ130; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24IME711; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24HME507; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24DMF364; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24CMI687; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24CMG984; Medline Kit Number/SKU DYNJ909065A: UDI/DI each 10195327460648, UDI/DI case 40195327460649, Lot Number: 24BMI425.
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. CATARACT PACK, Medline Kit Number/SKU DYNJ48725A; 2. OCULAR PACK, Medline Kit Number/SKU DYNJ64138B; 3. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572A; 4. OCULOPLASTY PACK, Medline Kit Number/SKU DYNJ64572B; 5. MICROSURGERY PACK, Medline Kit Number/SKU DYNJ67284A; 6. BASIC EYE PACK, Medline Kit Number/SKU DYNJ81411A; 7. SMR SINUS PACK, Medline Kit Number/SKU DYNJ84478; 8. FESS/SEPTO PACK, Medline Kit Number/SKU DYNJ85025; 9. PLASTIC EYE PACK, Medline Kit Number/SKU DYNJ89030; 10. NEURO, Medline Kit Number/SKU DYNJ902935K; 11. OCULAR, Medline Kit Number/SKU DYNJ909065; 12. OCULAR, Medline Kit Number/SKU DYNJ909065A.
- Recalling firm
- Medline Industries, LP
- Quantity
- 3290 kits
- Distribution
- Worldwide distribution.
- Recall date
- May 6, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)