HIGHFDA DEVICE

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU...

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 CDS983173G: UDI/DI each 10193489577402UDI/DI case 40193489577403Lot Number: 22EBQ566

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 CDS983173G: UDI/DI each 10193489577402, UDI/DI case 40193489577403, Lot Number: 22EBQ566, Lot Number: 22OBM500, Lot Number: 22BBH011, Lot Number: 22ABF773, Lot Number: 21KBM498, Lot Number: 21JBJ185

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. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO PACK-LF, Medline Kit Number/SKU DYNJ51677B; 5. RHINO/SEPTO/FESS PACK, Medline Kit Number/SKU DYNJ55955C; 6. NASAL PACK, Medline Kit Number/SKU DYNJ67789A.. 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: 1294 kits. Distribution: Worldwide distribution.

Safety Guide

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Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Medline Kit Number/SKU CDS983173G: UDI/DI each 10193489577402
UDI/DI case 40193489577403
Lot Number: 22EBQ566
Lot Number: 22OBM500
Lot Number: 22BBH011
+3 more
Report Date
May 6, 2026
Recall Status
ACTIVE

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