The Recall Desk
HighFDA (Devices)·Z-2020-2026·Announced 2026-05-06

Medline Medical Procedure Kits With Neuro Sponges Recalled

Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may be out-of-specification.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a medical device with a high-risk hazard (endotoxin contamination). Although no illnesses or injuries have been reported, endotoxin is a pyrogen that can cause serious adverse effects if present at elevated levels on sterile medical devices used in sensitive procedures.

Plain-English summary

Medline Industries, LP is recalling six models of medical procedure kits that contain Medline Neuro Sponges. The recalled kits are the ZALE STEREOTACTIC CDS (Kit Number CDS983173G), EPISTAXIS TRAY (DYNDA3240), RHINO PACK (DYNJ46504B), MSC SEPTO RHINO PACK-LF (DYNJ51677B), RHINO/SEPTO/FESS PACK (DYNJ55955C), and NASAL PACK (DYNJ67789A). Approximately 1,294 kits have been distributed worldwide.

During an internal review, Medline identified higher-than-endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. The FDA classified this as a Class II recall.

Healthcare facilities and providers who have received these kits should stop use and contact Medline for instructions on return or replacement. Patients who have received procedures using these kits should consult their healthcare provider if they have any concerns.

The recalled product

Product
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 PA
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical / Procedure Kits
Hazard
  • endotoxin
  • contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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
  • Lot Number: 21IBM809
  • Lot Number: 21IBE910
  • Lot Number: 21HBF657
  • Lot Number: 21FBQ527
  • Lot Number: 21EBC912
  • Medline Kit Number/SKU DYNDA3240: UDI/DI each 10198459589348
  • UDI/DI case 40198459589349
  • Lot Number: 26BBJ475
  • Lot Number: 25LBD824
  • Medline Kit Number/SKU DYNJ46504B: UDI/DI each 10193489715163
  • UDI/DI case 40193489715164
  • Lot Number: 21IME243

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category