CLASS II ONGOING Device recall · Reported 6 May 2026 · FDA Enforcement Report
Medline medical procedure kits recalled by Medline Industries
Medline Industries is recalling Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: VP. The recall was initiated on 19 Mar 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2017-2026
- FDA event ID
- 98664
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Mar 2026
- FDA classified
- 30 Apr 2026
- Reported
- 6 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Mar 2026 | Recall initiated by company | |
| 30 Apr 2026 | Classified by FDA | +42 days |
| 6 May 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
Worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
25 other products · FDA event 98664This product is part of a recall event; the main page for the event is Medline Neuro Sponges, various dimensions, labeled as recalled.
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