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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 1,294
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.
Part of a larger recall action
This product is one of 31 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 31 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Detachment Risk
FDA (Devices) · 2026-10-14
- SevereMedline Homecare Bed Hand Pendants Recalled for Fire Hazard
FDA (Devices) · 2026-10-07
- SevereMedline Homecare Beds Recalled for Fire Hazard in Hand Control Pendant
FDA (Devices) · 2026-10-07
- HighMedline Instrument Channel Brush Kits Recalled for Sharp Edges
FDA (Devices) · 2026-09-30
Same hazard · endotoxin
See all →- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- SevereMedline Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30
- HighMedline Craniotomy Kits Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- HighMedline Neurosponge Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline Neurosurgical Kits Recalled for Endotoxin Contamination
FDA (Devices) · 2026-09-02
- HighMedline Medical Convenience Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline Surgical Procedure Kits Recalled Due to Sterility Concerns
FDA (Devices) · 2025-01-08
- HighMedline Surgical Procedure Kits Recalled for Non-Sterile Components
FDA (Devices) · 2025-01-08
- HighMedline surgical procedure kits recalled for non-sterile supplies
FDA (Devices) · 2025-01-08