Medline Neuro Sponges in Pediatric Airway Kits recalled for endotoxin
Medline Industries is recalling Pediatric Airway 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 of a high-risk medical device (neuro sponges used in airway procedures) with a documented out-of-specification condition (endotoxin contamination) that poses a potential risk of harm. The source does not report any illnesses or injuries, but endotoxin on medical devices in airway procedures represents a significant health risk.
Plain-English summary
Medline Industries, LP is recalling Medline medical procedure kits containing Medline Neuro Sponges, specifically the PEDS AIRWAY PACK with kit number SKU DYNJ86657A. The recall affects 306 kits that were distributed worldwide.
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative neuro sponge product, indicating that in-market product may be out of specification for endotoxin content. Endotoxin is a bacterial component that can cause adverse health effects.
The affected kits bear the following identifiers: UDI/DI each 10198459431678, UDI/DI case 40198459431679, and lot numbers 26ABM977, 25KBM387, 25IBG995, and 25GBW704. Healthcare facilities and users of these kits should contact Medline Industries, LP for instructions on product return or replacement.
The recalled product
- Product
- Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: PEDS AIRWAY PACK, Medline Kit Number SKU DYNJ86657A
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 306
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 (6)
- Medline Kit Number SKU DYNJ86657A: UDI/DI each 10198459431678
- UDI/DI case 40198459431679
- Lot Numbers: 26ABM977
- 25KBM387
- 25IBG995
- 25GBW704.
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.
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