Medline Convenience Kits: 1) PEDS SINUS PACK, Catalog Number: DYNJ02516G; 2) SINUS PACK-LF, Catalog Number: DYNJ0342705J; 3) NASAL-LF, Cata…
Medline Industries, LP · The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present heal…
Open FDA's page for this record- Cfres ID
- 222385
- Product res number
- Z-3265-2026
- Event date initiated
- 2026-08-10
- Event date posted
- 2026-09-24
- Recall status
- Open, Classified
- Res event number
- 99739
- Product code
- OGR
- Firm FEI number
- 1417592
- Recalling firm
- Medline Industries, LP
- Address 1
- 3 Lakes Dr
- City
- Northfield
- State
- IL
- Postal code
- 60093-2753
- Additional info contact
- Haley Barclay 866-359-1704
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 695 kits
- Distribution pattern
- US Nationwide.
- Product description
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
- Code info
1) DYNJ02516G, UDI-DI: 10889942295234(each), 40889942295235(case), Lot Number: 22HME611; 2) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23GMI728; 3) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23EME909; 4) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23CMG752; 5) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23CMB449; 6) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 23AMI951; 7) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 22KMD941; 8) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 22JMC071; 9) DYNJ0342705J, UDI-DI: 10193489514001(each), 40193489514002(case), Lot Number: 22FMD388; 10) DYNJ40094G, UDI-DI: 10195327170813(each), 40195327170814(case), Lot Number: 23HMA901; 11) DYNJ50699F, UDI-DI: 10193489826555(each), 40193489826556(case), Lot Number: 23HMA420; 12) DYNJ83219, UDI-DI: 10195327247720(each), 40195327247721(case), Lot Number: 23GBH079; 13) DYNJ83219, UDI-DI: 10195327247720(each), 40195327247721(case), Lot Number: 23FBB663; 14) DYNJ83219, UDI-DI: 10195327247720(each), 40195327247721(case), Lot Number: 23DBS195; 15) DYNJ83219, UDI-DI: 10195327247720(each), 40195327247721(case), Lot Number: 22LBG199
- Reason for recall
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
- Action
An "URGENT MEDICAL DEVICE RECALL" notification letter dated 8/10/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-159-FGX1 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Harmonized identifiers (openFDA)
- Device name
- Ear, Nose, And Throat Surgical Tray
- Medical specialty description
- Ear, Nose, Throat
- Regulation number
- 874.4420
- Device class
- 1
- Registration number
- 3026197444, 1422634, 3004911384, 3004519921, 3012811961, 3009203853, 3018077422, 1043214, 3010041511, 3004111573, 9616088, 3014925393, 1030451, 1047429, 1423395, 2029015, 3004122598, 3011137372, 1423537, 1643817, 3007329020, 1923569, 2320762, 1061124, 1928237, 3004362278, 3015173212, 3005595283, 3005012805, 1824619, 1054241, 3003418325, 1055236, 3035642068, 3001084743, 3009888344, 3045816902
- FEI number
- 3026197444, 3002902735, 3004911384, 3012811961, 3003040625, 3009203853, 1000514656, 3018077422, 1043214, 3010041511, 3004111573, 3014925393, 1030451, 3000717925, 1047429, 3004122598, 1000112968, 1643817, 3001084743, 3007329020, 1923569, 1928237, 3005747797, 3004362278, 3015173212, 3005595283, 3005012805, 1000112877, 1000160458, 1824619, 3003418325, 1000512168, 3035642068, 3005846326, 3001236905, 3009888344, 3045816902
