Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056…
Medline Industries, LP · Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out…
Open FDA's page for this record- Cfres ID
- 221663
- Product res number
- Z-2995-2026
- Event date initiated
- 2026-07-08
- Event date posted
- 2026-08-21
- Recall status
- Open, Classified
- Res event number
- 99489
- Product code
- LRO
- 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 800-359-1704
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 246 kits
- Distribution pattern
- US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.
- Product description
Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641.
- Code info
Medline SKU Number DYNJT6545, UDI 10198459558757 (each) 40198459558758 (case), Lot Number 25JMG396; Medline SKU Number DYNJT6545, UDI 10198459558757 (each) 40198459558758 (case), Lot Number 26AMH848; Medline SKU Number DYNJ88056A, UDI 10198459372667 (each) 40198459372668 (case), Lot Number 25FMD894; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25JMH786; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25KMF523; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 25KMF530; Medline SKU Number DYNJ89001, UDI 10198459258961 (each) 40198459258962 (case), Lot Number 26CMD479; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 24ABD437; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 24ABO388; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 23EBA762; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 23HBG168; Medline SKU Number DYNJ908641, UDI 10195327123819 (each) 40195327123810 (case), Lot Number 23KBW672.
- Reason for recall
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
- Action
Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 7/8/2026 via USPS and email. The notice explained the issue, potential adverse health consequences, and requested the following: "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-26-112-FGX2 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." For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
- K numbers
- K213481
- Harmonized identifiers (openFDA)
- Device name
- General Surgery Tray
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4370
- Device class
- 2
- K number
- K873973, K970286, K951478, K930270, K920267, K944044, K914174, K212258, K935686, K882684, K925214, K871434, K922648, K931673, K935741, K932220, K931824, K883250, K925216, K931760, K963721, K914935, K871873, K902887, K894685, K963715, K871322, K923600, K962826, K945831, K952539, K936117, K961863, K931844, K934688, K950295, K905004, K970187, K971061, K963443 +70 more
- Registration number
- 3010166880, 1721686, 3005246893, 3042480961, 3006271008, 1823410, 8022032, 3011707784, 3009203853, 8022210, 1063382, 1527607, 3004911384, 3004513970, 3011545608, 3017430544, 3012811961, 3010878085, 1928237, 1921846, 1644019, 3003495693, 3014325891, 3045857302, 1424263, 3026197444, 3005595283, 3014704068, 2000028362, 1423537, 3016761372, 9611594, 3044906632, 3007829657, 3009637528, 3002807314, 3012595397, 3013466775, 2011171, 3004362278 +123 more
- FEI number
- 3010166880, 1721686, 3005246893, 3042480961, 3006271008, 1823410, 3011707784, 3009203853, 3000718854, 1527607, 3004911384, 3003015552, 3194, 3004513970, 3011545608, 3017430544, 3012811961, 3000717925, 3010878085, 1928237, 1921846, 1000113384, 3045857302, 3003495693, 3014325891, 2523865, 3026197444, 3005595283, 3003803331, 3014704068, 2000028362, 3016761372, 3044906632, 3007829657, 3009637528, 3008373372, 3002807314, 3012595397, 3013466775, 3001236905 +123 more