| | Class 2 Device Recall Medline Neuro Sponge |  |
| Date Initiated by Firm | March 19, 2026 |
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| Date Posted | April 30, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2026-2026 |
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| Recall Event ID |
98664 |
| Product Classification |
Kit, surgical instrument, disposable - Product Code KDD
|
| Product | Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:
1. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ0532910L;
2. NEURO BASIN PACK-LF, Medline Kit Number/SKU DYNJ39461J;
3. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060I;
4. PK-MAD,SPINE, Medline Kit Number/SKU DYNJ58060J;
5. NEURO BASIN KIT, Medline Kit Number/SKU DYNJ80200B;
6. NEURO-SPINE BASIN PACK, Medline Kit Number/SKU DYNJ83019;
7. ENT PACK, Medline Kit Number/SKU DYNJ86328;
8. EDMOND SPINE PACK, Medline Kit Number/SKU DYNJ89263;
9. ENT PACK, Medline Kit Number/SKU DYNJ89675;
10. ENT PACK, Medline Kit Number/SKU DYNJ89675A;
11. ENT/PAIN PACK, Medline Kit Number/SKU DYNJT7493. |
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| Code Information |
Medline Kit Number/SKU DYNJ0532910L: UDI/DI each 10198459503870, UDI/DI case 40198459503871, Lot Number: 25IMD003;
Medline Kit Number/SKU DYNJ0532910L: UDI/DI each 10198459503870, UDI/DI case 40198459503871, Lot Number: 25HMH643;
Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 22GBS127;
Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 22FBB472;
Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25FBE752;
Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25EBA260;
Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25DBG176;
Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25CBD819;
Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 25BBA593;
Medline Kit Number/SKU DYNJ39461J: UDI/DI each 10195327112721, UDI/DI case 40195327112722, Lot Number: 24KBJ163;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23KMI415;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23JMK023;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23JMB211;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23IMC591;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23HMG291;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23GMG136;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23FME285;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23EME227;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 23CMD903;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24KMI915;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24KMH419;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24JMG571;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24HMF066;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24FMG130;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24CMI441;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24BMD229;
Medline Kit Number/SKU DYNJ58060I: UDI/DI each 10195327326159, UDI/DI case 40195327326150, Lot Number: 24AMH016;
Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 26BMB944;
Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 26AMJ197;
Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25KMC587;
Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25JMD275;
Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25IMC944;
Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25GMF811;
Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25FME706;
Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25EMA516;
Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 25CME296;
Medline Kit Number/SKU DYNJ58060J: UDI/DI each 10198459210662, UDI/DI case 40198459210663, Lot Number: 24LMD726;
Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 22HBH553;
Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 26BBF722;
Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25JBB835;
Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBO944;
Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBL998;
Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBH356;
Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25EBF751;
Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25DBB435;
Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 25BBC547;
Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 24KBR868;
Medline Kit Number/SKU DYNJ80200B: UDI/DI each 10195327213978, UDI/DI case 40195327213979, Lot Number: 24JBV969;
Medline Kit Number/SKU DYNJ83019: UDI/DI each 10195327228842, UDI/DI case 40195327228843, Lot Number: 23BBB952;
Medline Kit Number/SKU DYNJ83019: UDI/DI each 10195327228842, UDI/DI case 40195327228843, Lot Number: 23BBC125;
Medline Kit Number/SKU DYNJ83019: UDI/DI each 10195327228842, UDI/DI case 40195327228843, Lot Number: 22JBR211;
Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25LBS635;
Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25KBE004;
Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25HBR489;
Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25FBL484;
Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25DBD392;
Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 25ABD635;
Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 24KBB462;
Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 24JBE518;
Medline Kit Number/SKU DYNJ86328: UDI/DI each 10195327622381, UDI/DI case 40195327622382, Lot Number: 24GBE890;
Medline Kit Number/SKU DYNJ89263: UDI/DI each 10198459253348, UDI/DI case 40198459253349, Lot Number: 25BBK629;
Medline Kit Number/SKU DYNJ89675: UDI/DI each 10198459281693, UDI/DI case 40198459281694, Lot Number: 25CME067;
Medline Kit Number/SKU DYNJ89675A: UDI/DI each 10198459417436, UDI/DI case 40198459417437, Lot Number: 26AMG054;
Medline Kit Number/SKU DYNJ89675A: UDI/DI each 10198459417436, UDI/DI case 40198459417437, Lot Number: 26AMA771;
Medline Kit Number/SKU DYNJ89675A: UDI/DI each 10198459417436, UDI/DI case 40198459417437, Lot Number: 25GME903;
Medline Kit Number/SKU DYNJT7493: UDI/DI each 10198459626258, UDI/DI case 40198459626259, Lot Number: 26ABA254. |
| 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 |
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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. |
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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 | 9805 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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