FDA Medical Device Recalls (openFDA)

Medline Industries, LP: 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.

Recall number: Z-2026-2026
Recalling firm: Medline Industries, LP
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.
Status: Open, Classified
Initiated: 2026-03-19
Posted: 2026-04-30
Terminated: not on file
Reason: 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.
Root cause: Under Investigation by firm
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.
Quantity: 9805 kits
Distribution: Worldwide distribution.
Lot, serial or model codes: 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.
510(k) numbers: not on file
PMA numbers: not on file
Product code: KDD
Firm FEI: 1417592
Firm city: Northfield
Firm state: IL
Firm country: not on file

Where this comes from

Register: FDA Medical Device Recalls (openFDA)
Publisher: U.S. Food and Drug Administration (openFDA)
File: device-recall-0001-of-0001.json.zip
sha256: b87518bfe2e8
Size: 288210821 bytes
Published: 2026-09-28
Read: 2026-09-29T08:25:23.626Z
Source file: Source file retained · verify
Refresh due: 2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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