Medline medical procedure kits with neuro sponges recalled for endotoxin
Medline Industries is recalling approximately 7004 medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that indicate out-of-specification product.
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 biological hazard (endotoxin) that could cause adverse health consequences. Although no illnesses or injuries are reported in the source text, endotoxin contamination on products used in invasive procedures such as cervical fusion and obstetric applications presents a risk of harm without reported adverse events, which meets the High (3) severity threshold.
Plain-English summary
Medline Industries, LP is recalling approximately 7004 Medline medical procedure kits that contain Medline Neuro Sponges. The affected kits include Anterior Cervical Fusion Pack (SKU DYNJ40566C), OB Pack (SKU DYNJ47491F), and three variants of Anterior Cervical-LF kits (SKUs DYNJ58274, DYNJ58344, and DYNJS3016).
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product. This indicates that in-market product may be out-of-specification for endotoxin. The kits were distributed worldwide.
Patients and healthcare facilities that have received any of these kits should check the affected Lot Numbers and SKUs listed on the FDA website. Facilities should contact Medline Industries for guidance on the recalled kits. Healthcare providers should consult with Medline or the FDA if there are questions about whether specific inventory is affected.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ANTERIOR CERVICAL FUSION PACK, Medline Kit Number/SKU DYNJ40566C; 2. OB PACK (OBSJD)642-LF, Medline Kit Number/SKU DYNJ47491F; 3. ANTERIOR CERVICAL-LF, Medline Kit Number/SKU…
- Manufacturer
- Medline Industries, LP
- Affected units
- 7,004
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 DYNJ40566C: UDI/DI each10889942469659
- UDI/DI case 40889942469650
- Lot Number: 22BBJ540
- Lot Number: 21LBM539
- Lot Number: 21IBX286
- Lot Number: 21HBM832
- Medline Kit Number/SKU DYNJ47491F: UDI/DI each10193489586725
- UDI/DI case 40193489586726
- Lot Number: 21KMD114
- Medline Kit Number/SKU DYNJ58274: UDI/DI each10889942840724
- UDI/DI case 40889942840725
- Lot Number: 22FMI371
- Lot Number: 21IMD775
- Medline Kit Number/SKU DYNJ58344: UDI/DI each10889942841721
- UDI/DI case 40889942841722
- Lot Number: 23JBD782
- Lot Number: 23HBY508
- Lot Number: 23GBQ615
- Lot Number: 23EBR984
- Lot Number: 23EBD017
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 Detachment Risk
FDA (Devices) · 2026-10-14
- SevereMedline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk
FDA (Devices) · 2026-10-14
- SevereMedline Homecare Beds Recalled for Fire Hazard in Hand Control Pendant
FDA (Devices) · 2026-10-07
- SevereMedline Homecare Bed Hand Pendants Recalled for Fire Hazard
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 Craniotomy Kits 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 Neurological Sponges Recalled for Potential Endotoxin Variability
FDA (Devices) · 2026-09-30
Similar recalls
- HighMedline Neurosurgical Kits Recalled for Endotoxin Contamination
FDA (Devices) · 2026-09-02
- HighMedline Surgical Procedure Kits Recalled Due to Sterility Concerns
FDA (Devices) · 2025-01-08
- HighMedline Neurosponge Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline Medical Convenience Kits Recalled for Endotoxin Levels
FDA (Devices) · 2026-09-02
- HighMedline surgical procedure kits recalled for non-sterile supplies
FDA (Devices) · 2025-01-08
- HighMedline Neurological Surgery Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-09-30