Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SH...
FDA Device Recall #Z-2017-2026 — Class II — March 19, 2026
Recall Summary
| Recall Number | Z-2017-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 19, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 3588 kits |
Product Description
Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. VP SHUNT, Medline Kit Number/SKU CDS840193V; 2. SHY VP SHUNT CDS, Medline Kit Number/SKU CDS982389J; 3. VP SHUNT ADULT PACK-LF, Medline Kit Number/SKU DYNJ0117497G; 4. PICC LINE PACK, Medline Kit Number/SKU DYNJ04592K; 5. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993L; 6. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933F; 7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861B; 8. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861D; 9. EVD VP SHUNT DBS PACK 319705, Medline Kit Number/SKU DYNJ44603C; 10. BURR HOLE SHUNT PACK, Medline Kit Number/SKU DYNJ56819G; 11. CHRISTUS CHILDRENS VP SHUNT PK, Medline Kit Number/SKU DYNJ61174A; 12. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213C; 13. FREE FLAP PACK, Medline Kit Number/SKU DYNJ68213F; 14. NASAL ENDO PACK, Medline Kit Number/SKU DYNJ84501; 15. RO VP SHUNT PACK, Medline Kit Number/SKU PHS392834010D.
Reason for Recall
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Distribution Pattern
Worldwide distribution.
Lot / Code Information
Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23JBW804; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23JBX015; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23JBD094; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23IBQ501; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23FBO564; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23EBW686; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 23DBO524; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22GBU281; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBR456; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBM213; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22EBN031; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22DBP331; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22MBA145; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 22ABM907; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21KBE066; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21JBE527; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBH244; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBE520; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21HBE521; Medline Kit Number/SKU CDS840193V: UDI/DI each 10193489822540, UDI/DI case 40193489822541, Lot Number : 21FBC630; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22IBU058; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22HBH306; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22GBQ912; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22DBT185; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 22DBI063; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21IBM934; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21GBN290; Medline Kit Number/SKU CDS982389J: UDI/DI each 10193489242553, UDI/DI case 40193489242554, Lot Number : 21DBG187; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21IBP593; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21HBA351; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21GBE684; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21GBA846; Medline Kit Number/SKU DYNJ0117497G: UDI/DI each 10193489896541, UDI/DI case 40193489896542, Lot Number : 21FBI072; Medline Kit Number/SKU DYNJ04592K: UDI/DI each 10193489215205, UDI/DI case 40193489215206, Lot Number : 23JLA230; Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 22FBH340; Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 21CKA561; Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 21BKA591; Medline Kit Number/SKU DYNJ0750993L: UDI/DI each 10193489201390, UDI/DI case 40193489201391, Lot Number : 21AKB149; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23KBE105; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23JBH870; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23IBS256; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23HBW099; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 23EBB384; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 22JBP897; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABI491; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABG881; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABH208; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABF236; Medline Kit Number/SKU DYNJ0753933F: UDI/DI each 10193489283273, UDI/DI case 40193489283274, Lot Number : 21ABB836; Medline Kit Number/SKU DYNJ39861B: UDI/DI each 10193489477511, UDI/DI case 40193489477512, Lot Number : 21KMH013; Medline Kit Number/SKU DYNJ39861B: UDI/DI each 10193489477511, UDI/DI case 40193489477512, Lot Number : 21JME705; Medline Kit Number/SKU DYNJ39861B: UDI/DI each 10193489477511, UDI/DI case 40193489477512, Lot Number : 21JMD611; Medline Kit Number/SKU DYNJ39861B: UDI/DI each 10193489477511, UDI/DI case 40193489477512, Lot Number : 21IME971; Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 26BME412; Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 26AMJ494; Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 25KMG940; Medline Kit Number/SKU DYNJ39861D: UDI/DI each 10198459433559, UDI/DI case 40198459433550, Lot Number : 25GMH433; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23KBN958; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23JBH478; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23HBT146; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23GBG624; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23CBC001; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23ABU575; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 23ABL787; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22LBM663; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22LBJ926; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22JBG520; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22IBR340; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22EBU759; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22DBR774; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22BBZ813; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 22BBZ792; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21KBG387; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21IBR350; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21GBV108; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21FBJ559; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21DBE602; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 21CBJ874; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 26BBI620; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 26BBA242; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25JBD488; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25HBM158; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25GBE204; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25EBR912; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25BBU542; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 25ABW421; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24KBO504; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24JBM902; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24IBK100; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24GBE540; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24FBK645; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24DBS967; Medline Kit Number/SKU DYNJ44603C: UDI/DI each 10193489767032, UDI/DI case 40193489767033, Lot Number : 24BBG984; Medline Kit Number/SKU DYNJ56819G: UDI/DI each 10195327073749, UDI/DI case 40195327073740, Lot Number : 22HBB961; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21KLA936; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21JLA574; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21HLA401; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21GLB120; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21GLA452; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21GLA295; Medline Kit Number/SKU DYNJ61174A: UDI/DI each 10193489860740, UDI/DI case 40193489860741, Lot Number : 21CLA652; Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 23IMI021; Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 24HMA726; Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 24GMI771; Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 24DMB264; Medline Kit Number/SKU DYNJ68213C: UDI/DI each 10195327511999, UDI/DI case 40195327511990, Lot Number : 23KMJ671; Medline Kit Number/SKU DYNJ68213F: UDI/DI each 10198459501173, UDI/DI case 40198459501174, Lot Number : 25IMD349; Medline Kit Number/SKU DYNJ84501: UDI/DI each 10195327371845, UDI/DI case 40195327371846, Lot Number : 23GBI579; Medline Kit Number/SKU DYNJ84501: UDI/DI each 10195327371845, UDI/DI case 40195327371846, Lot Number : 24ABL755; Medline Kit Number/SKU DYNJ84501: UDI/DI each 10195327371845, UDI/DI case 40195327371846, Lot Number : 23LBC527; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22CDC077; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22ADC035; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22ADB161; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 22ADA979; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21LDA084; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21HDB299; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21DDC112; Medline Kit Number/SKU PHS392834010D: UDI/DI each 10193489222432, UDI/DI case 40193489222433, Lot Number : 21ADC003.
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2235-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2237-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2236-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2234-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2232-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.