HIGHFDA DEVICE

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....

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.

Medline Industries, LPHealth & Personal CareMedical DevicesMedline Kit Number/SKU DYNJ48725A: UDI/DI each 10193489853896UDI/DI case 40193489853897Lot Number: 24IMG757

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
March 19, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
March 19, 2026
Hazard Level
HIGH
Brand
Medline Industries, LP

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Medline Industries, LP
Model numbers
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, Lot Number: 22DMC340, Lot Number: 21JMC829 +2 more

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    March 19, 2026

  2. Reported by FDA DEVICE

    May 6, 2026

  3. RecallRadar source check

    May 13, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

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 You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Full Description

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.. 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.. Classification: Class II. Quantity: 3290 kits. Distribution: Worldwide distribution.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
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
+5 more
Report Date
May 6, 2026
Recall Status
ACTIVE

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