Medline Industries, LP recalls Medline medical convenience kits
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4) CRANIOTOMY PACK, Medline Kit SKU DYNJ46024F; 5) SPINE PACK, Medline Kit SKU DYNJ54479C; 6) CRANIOTOMY PACK, Medline Kit SKU DYNJ58006B; 7) ORTHO-LAMINECTOMY PACK, Medline Kit SKU DYNJ58014A; 8) SPINE PACK, Medline Kit SKU DYNJ83585; 9) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056; 10) CRANI MT CARMEL, Medline Kit SKU DYNJ900467I; 11) GP-NEURO SPINE PACK-LF, Medline Kit SKU PHS396933009C.
Lot / code information
- Lot #
- 25JMF561; Medline Kit SKU DYNJ44504G, UDI/DI 10198459241956 (each) 40198459241957 (case)
- Lot #
- 25EDA305; Medline Kit SKU DYNJ44504G, UDI/DI 10198459241956 (each) 40198459241957 (case)
- Lot #
- 25EDB254; Medline Kit SKU DYNJ45419F, UDI/DI 10195327625689 (each) 40195327625680 (case)
- Lot #
- 24JMF418; Medline Kit SKU DYNJ45419F, UDI/DI 10195327625689 (each) 40195327625680 (case)
- Lot #
- 24JMJ129; Medline Kit SKU DYNJ46024F, UDI/DI 10195327237011 (each) 40195327237012 (case)
- Lot #
- 23HBJ773; Medline Kit SKU DYNJ54479C, UDI/DI 10193489460254 (each) 40193489460255 (case)
- Lot #
- 23HBA720; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case)
- Lot #
- 23BMC930; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case)
- Lot #
- 23FMD505; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case)
- Lot #
- 23JMH313; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case)
- Lot #
- 23LME066; Medline Kit SKU DYNJ58006B, UDI/DI 10193489867381 (each) 40193489867382 (case)
- Lot #
- 22CMG565; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case)
- Lot #
- 24BME326; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case)
- Lot #
- 24EMF925; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case)
- Lot #
- 23AMJ184; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case)
- Lot #
- 23EMD739; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case)
- Lot #
- 23IME138; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case)
- Lot #
- 23KMB648; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case)
- Lot #
- 23LMB107; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case)
- Lot #
- 23LMH426; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case)
- Lot #
- 22FMF374; Medline Kit SKU DYNJ58014A, UDI/DI 10193489864007 (each) 40193489864008 (case)
- Lot #
- 22KMH219; Medline Kit SKU DYNJ83585, UDI/DI 10195327283179 (each) 40195327283170 (case)
- Lot #
- 23HMC695; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case)
- Lot #
- 25CMD816; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case)
- Lot #
- 24IMD021; Medline Kit SKU DYNJ88056, UDI/DI 10198459092725 (each) 40198459092726 (case)
- Lot #
- 24IME838; Medline Kit SKU DYNJ900467I, UDI/DI 10195327181338 (each) 40195327181339 (case)
- Lot #
- 23IBJ627; Medline Kit SKU DYNJ900467I, UDI/DI 10195327181338 (each) 40195327181339 (case)
- Lot #
- 23IBL564; Medline Kit SKU PHS396933009C, UDI/DI 10193489753301 (each) 40193489753302 (case)
- Lot #
- 22EDB595
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What the firm is doing
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.
DistributionShow detailsHide
US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2997-2026
- FDA device classification · OJHOfficial FDA classification for this device type
- CFR regulation · 21 CFR 878.4800The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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