Medline Neurological Sponges Recalled for Potential Endotoxin Variability
Medline is recalling 695 convenience kits containing neurological sponges due to potential endotoxin variability that may cause adverse health reactions.
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: The recall is classified as FDA Class II, and the source text describes potential health risks requiring medical intervention (such as neurovascular adverse events) without reporting specific confirmed injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 695 convenience kits, including the PEDS SINUS PACK, SINUS PACK-LF, NASAL-LF, ENT PACK, and EENT PACK, distributed nationwide in the United States. The recall is due to the presence of neurological sponges within these kits that have the potential for unexpected variability in endotoxin levels.
Potentially elevated endotoxin levels may present health risks that could require medical intervention. The source text notes that these risks include neurovascular adverse events, febrile response, local transient inflammation, hypotension, or nausea.
The affected products are identified by specific catalog numbers and lot numbers, including DYNJ02516G (Lot 22HME611), DYNJ0342705J (Lots 23GMI728, 23EME909, 23CMG752, 23CMB449, 23AMI951, 22KMD941, 22JMC071, 22FMD388), DYNJ40094G (Lot 23HMA901), DYNJ50699F (Lot 23HMA420), and DYNJ83219 (Lots 23GBH079, 23FBB663, 23DBS195, 22LBG199). Healthcare providers and consumers should check their inventory for these specific lot numbers and discontinue use of the affected kits.
The recalled product
- Product
- Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Catalog Number: DYNJ40094G; 4) ENT PACK, Catalog Number: DYNJ50699F; 5) EENT PACK, Catalog Number: DYNJ83219
- Manufacturer
- Medline Industries, LP
- Affected units
- 695
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)
- 1) DYNJ02516G
- UDI-DI: 10889942295234(each)
- 40889942295235(case)
- Lot Number: 22HME611
- 2) DYNJ0342705J
- UDI-DI: 10193489514001(each)
- 40193489514002(case)
- Lot Number: 23GMI728
- 3) DYNJ0342705J
- Lot Number: 23EME909
- 4) DYNJ0342705J
- Lot Number: 23CMG752
- 5) DYNJ0342705J
- Lot Number: 23CMB449
- 6) DYNJ0342705J
- Lot Number: 23AMI951
- 7) DYNJ0342705J
- Lot Number: 22KMD941
- 8) DYNJ0342705J
- Lot Number: 22JMC071
Distribution
Distributed nationwide across the United States.
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