The Recall Desk
HighFDA (Devices)·Z-2036-2026·Announced 2026-05-06

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.

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 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 DYNJ58274;
Manufacturer
Medline Industries, LP
Category
Medical Device — Surgical / Procedural Kits
Hazard
  • endotoxin
  • bacterial-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 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.

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