| | Class 2 Device Recall Medline Neuro Sponge |  |
| Date Initiated by Firm | March 19, 2026 |
|---|
| Date Posted | April 30, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2037-2026 |
|---|
| Recall Event ID |
98664 |
| Product Classification |
Eye tray - Product Code OJK
|
| 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. |
|---|
| Code Information |
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. |
| FEI Number |
1417592
|
Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay
800-359-1704 |
|---|
Manufacturer Reason
for Recall | 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. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 3/19/2026 via USPS first class mail and email. The notice explained the issue, potential health risk, and requested the following actions be taken on the affected sponges: Identify and quarantine affected product, complete response form using website link: https://recalls.medline.com, destroy affected product. Credit will be issued once response form is received. If the product has been further distributed, sold, or transferred, notify the customer to destroy the product. Distributors must notify their customers and should include customer quantities on your response form. For consignees of Medline medical convenience kits containing the affected sponges the actions to be taken are as follows: Identify and quarantine all affected kits, complete response form using website link: https://recalls.medline.com. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. Distributors must notify their customers and should include customer quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product.
If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
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| Quantity in Commerce | 3290 kits |
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| Distribution | Worldwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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