Class II FDA device recall · Z-2016-2026

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI; 2. OPEN HEART CDS, Medline Kit Number/SKU CDS984890V; 3. RR-NEURO VASCULAR PACK-LF, Medline Kit Number/SKU DYNJ0394874L; 4. VP SHUNT PACK-LF, Medline Kit Number/SKU DYNJ0750993M; 5. PEDI VP SHUNT ADD A PACK-LF, Medline Kit Number/SKU DYNJ0753933G; 6. FESS-MB PACK-LF, Medline Kit Number/SKU DYNJ0888159I; 7. A-V FISTULA PACK GH-LF, Medline Kit Number/SKU DYNJ39861C; 8. POSTERIOR LUMBAR PACK, Medline Kit Number/SKU DYNJ42626B; 9. CV CUTDOWN PACK, Medline Kit Number/SKU DYNJ45374F; 10. X RAY CLOSED PACK, Medline Kit Number/SKU DYNJ48949C; 11. RFD- AAA PACK, Medline Kit Number/SKU DYNJ54242B; 12. NEURO LAM, Medline Kit Number/SKU DYNJ64188A; 13. LIVE OAK SINUS ENDOSCOPY PACK, Medline Kit Number/SKU DYNJ69223; 14. FEM POP PACK, Medline Kit Number/SKU DYNJ81423C; 15. ENS FREEFLAP PROCDURE - LF, Medline Kit Number/SKU DYNJ88249; 16. OPEN HEART A&B, Medline Kit Number/SKU DYNJ901203D; 17. NEURO ACD, Medline Kit Number/SKU DYNJ904549F; 18. KIT VP SHUNT RFD, Medline Kit Number/SKU DYNJ906303F; 19. ACDF-LF, Medline Kit Number/SKU DYNJ906681C; 20. ACDF-LF, Medline Kit Number/SKU DYNJ906681D; 21. ACDF-LF, Medline Kit Number/SKU DYNJ906681F; 22. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196B; 23. UNIVERSITY FREE FLAP, Medline Kit Number/SKU DYNJ907196C; 24. ENDOSCOPIC SKULL BASE, Medline Kit Number/SKU DYNJ908362F; 25. VP SHUNT, Medline Kit Number/SKU DYNJ909379; 26. VP SHUNT, Medline Kit Number/SKU DYNJ909379A.

Why it was 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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

Medline Kit Number/SKU CDS840402AI:  UDI/DI each 10195327334024, UDI/DI case 40195327334025, Lot Number: 23JLA668;  Medline Kit Number/SKU CDS840402AI:  UDI/DI each 10195327334024, UDI/DI case 40195327334025, Lot Number: 23JLA240;  Medline Kit Number/SKU CDS984890V:  UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25IMG470;  Medline Kit Number/SKU CDS984890V:  UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25GMI158;  Medline Kit Number/SKU CDS984890V:  UDI/DI each 10198459374364, UDI/DI case 40198459374365, Lot Number: 25GMC404;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23ILA647;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23HLA953;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23GLA064;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 23ELA715;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22KLB111;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22GLB222;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22ELA384;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22ELA314;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22CLA246;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22BLA951;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 22ALB037;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21KLA949;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21KLA323;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21JLA776;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21ILA612;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21HLA761;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21CKA431;  Medline Kit Number/SKU DYNJ0394874L:  UDI/DI each 10193489800005, UDI/DI case 40193489800006, Lot Number: 21AKA070;  Medline Kit Number/SKU DYNJ0750993M:  UDI/DI each 10195327196721, UDI/DI case 40195327196722, Lot Number: 22HMA046;  Medline Kit Number/SKU DYNJ0753933G:  UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 25BMB856;  Medline Kit Number/SKU DYNJ0753933G:  UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 25BMA099;  Medline Kit Number/SKU DYNJ0753933G:  UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24KMD499;  Medline Kit Number/SKU DYNJ0753933G:  UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24IMH163;  Medline Kit Number/SKU DYNJ0753933G:  UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24FMC456;  Medline Kit Number/SKU DYNJ0753933G:  UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24EMF287;  Medline Kit Number/SKU DYNJ0753933G:  UDI/DI each 10195327587420, UDI/DI case 40195327587421, Lot Number: 24DBR793;  Medline Kit Number/SKU DYNJ0888159I:  UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23IMH609;  Medline Kit Number/SKU DYNJ0888159I:  UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23FMI503;  Medline Kit Number/SKU DYNJ0888159I:  UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23EMF428;  Medline Kit Number/SKU DYNJ0888159I:  UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23CMG922;  Medline Kit Number/SKU DYNJ0888159I:  UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23BMB904;  Medline Kit Number/SKU DYNJ0888159I:  UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23BMB800;  Medline Kit Number/SKU DYNJ0888159I:  UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23AMG570;  Medline Kit Number/SKU DYNJ0888159I:  UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 22CLA968;  Medline Kit Number/SKU DYNJ0888159I:  UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 21LLA678;  Medline Kit Number/SKU DYNJ0888159I:  UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 21LLA280;  Medline Kit Number/SKU DYNJ0888159I:  UDI/DI each 10195327050146, UDI/DI case 40195327050147, Lot Number: 23LMA074;  Medline Kit Number/SKU DYNJ39861C:  UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 23KMB808;  Medline Kit Number/SKU DYNJ39861C:  UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 23FMG346;  Medline Kit Number/SKU DYNJ39861C:  UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 22JME917;  Medline Kit Number/SKU DYNJ39861C:  UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 25BME921;  Medline Kit Number/SKU DYNJ39861C:  UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 24KMI331;  Medline Kit Number/SKU DYNJ39861C:  UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 24GMJ067;  Medline Kit Number/SKU DYNJ39861C:  UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 24CMD306;  Medline Kit Number/SKU DYNJ39861C:  UDI/DI each 10195327176839, UDI/DI case 40195327176830, Lot Number: 23KMJ792;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 23DMA752;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 23AMJ467;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 23AME117;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22LMH958;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22FMI351;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22DMG917;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22DME926;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22CME836;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22CME845;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 22AMB811;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21LMC202;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21IMF079;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21HMG746;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21HMB707;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21GMA214;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21FMD947;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21EME446;  Medline Kit Number/SKU DYNJ42626B:  UDI/DI each 10888277746336, UDI/DI case 40888277746337, Lot Number: 21DMA825;  Medline Kit Number/SKU DYNJ45374F:  UDI/DI each 10195327235338, UDI/DI case 40195327235339, Lot Number: 22HLB315;  Medline Kit Number/SKU DYNJ48949C:  UDI/DI each 10195327506421, UDI/DI case 40195327506422, Lot Number: 24EMG463;  Medline Kit Number/SKU DYNJ54242B:  UDI/DI each 10195327167097, UDI/DI case 40195327167098, Lot Number: 22EBN455;  Medline Kit Number/SKU DYNJ64188A:  UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 22FBC048;  Medline Kit Number/SKU DYNJ64188A:  UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 22EBL053;  Medline Kit Number/SKU DYNJ64188A:  UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 22ABY741;  Medline Kit Number/SKU DYNJ64188A:  UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 21LBR909;  Medline Kit Number/SKU DYNJ64188A:  UDI/DI each 10193489291063, UDI/DI case 40193489291064, Lot Number: 21GBN579;  Medline Kit Number/SKU DYNJ69223:  UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 23FBK303;  Medline Kit Number/SKU DYNJ69223:  UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 23DBJ838;  Medline Kit Number/SKU DYNJ69223:  UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 23BBG277;  Medline Kit Number/SKU DYNJ69223:  UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 22LBR825;  Medline Kit Number/SKU DYNJ69223:  UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 21HBA373;  Medline Kit Number/SKU DYNJ69223:  UDI/DI each 10193489917031, UDI/DI case 40193489917032, Lot Number: 21GBK168;  Medline Kit Number/SKU DYNJ81423C:  UDI/DI each 10195327580971, UDI/DI case 40195327580972, Lot Number: 24ALA997;  Medline Kit Number/SKU DYNJ88249:  UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 25HBG788;  Medline Kit Number/SKU DYNJ88249:  UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 25EBH390;  Medline Kit Number/SKU DYNJ88249:  UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 25DBO029;  Medline Kit Number/SKU DYNJ88249:  UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 24JBJ805;  Medline Kit Number/SKU DYNJ88249:  UDI/DI each 10198459139734, UDI/DI case 40198459139735, Lot Number: 24IBP006;  Medline Kit Number/SKU DYNJ901203D:  UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 26CMA719;  Medline Kit Number/SKU DYNJ901203D:  UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25KMA819;  Medline Kit Number/SKU DYNJ901203D:  UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25JMI928;  Medline Kit Number/SKU DYNJ901203D:  UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25IMH651;  Medline Kit Number/SKU DYNJ901203D:  UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25IMF255;  Medline Kit Number/SKU DYNJ901203D:  UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25EMC697;  Medline Kit Number/SKU DYNJ901203D:  UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 25EMA738;  Medline Kit Number/SKU DYNJ901203D:  UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 24LMF802;  Medline Kit Number/SKU DYNJ901203D:  UDI/DI each 10193489947526, UDI/DI case 40193489947527, Lot Number: 24KMI436;  Medline Kit Number/SKU DYNJ904549F:  UDI/DI each 10193489296518, UDI/DI case 40193489296519, Lot Number: 21BBN341;  Medline Kit Number/SKU DYNJ906303F:  UDI/DI each 10195327370961, UDI/DI case 40195327370962, Lot Number: 23KBC207;  Medline Kit Number/SKU DYNJ906303F:  UDI/DI each 10195327370961, UDI/DI case 40195327370962, Lot Number: 24CBF368;  Medline Kit Number/SKU DYNJ906303F:  UDI/DI each 10195327370961, UDI/DI case 40195327370962, Lot Number: 24BBS806;  Medline Kit Number/SKU DYNJ906681C:  UDI/DI each 10195327173838, UDI/DI case 40195327173839, Lot Number: 24KBP901;  Medline Kit Number/SKU DYNJ906681C:  UDI/DI each 10195327173838, UDI/DI case 40195327173839, Lot Number: 24JBS832;  Medline Kit Number/SKU DYNJ906681C:  UDI/DI each 10195327173838, UDI/DI case 40195327173839, Lot Number: 24JBS844;  Medline Kit Number/SKU DYNJ906681D:  UDI/DI each 10198459177835, UDI/DI case 40198459177836, Lot Number: 25EBT919;  Medline Kit Number/SKU DYNJ906681D:  UDI/DI each 10198459177835, UDI/DI case 40198459177836, Lot Number: 25EBG758;  Medline Kit Number/SKU DYNJ906681D:  UDI/DI each 10198459177835, UDI/DI case 40198459177836, Lot Number: 25CBE651;  Medline Kit Number/SKU DYNJ906681F:  UDI/DI each 10198459408786, UDI/DI case 40198459408787, Lot Number: 26BBF426;  Medline Kit Number/SKU DYNJ906681F:  UDI/DI each 10198459408786, UDI/DI case 40198459408787, Lot Number: 26ABT746;  Medline Kit Number/SKU DYNJ906681F:  UDI/DI each 10198459408786, UDI/DI case 40198459408787, Lot Number: 25IBS840;  Medline Kit Number/SKU DYNJ906681F:  UDI/DI each 10198459408786, UDI/DI case 40198459408787, Lot Number: 25HBV440;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23KBH640;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23JBS928;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23JBO465;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23IBU560;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23IBW411;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23GBP575;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23GBL027;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23CBP004;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23CBI477;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23ABL781;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23ABF479;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 22JBR772;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 22IBU581;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 22FBP794;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 22OBE661;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 22OBD412;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 25GBX281;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 25FBV649;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 25DBC300;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 25BBQ176;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 25ABS828;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24KBR012;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24JBW006;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24JBU927;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24JBD576;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24HBI996;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24HBA457;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24FBE346;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 24DBR244;  Medline Kit Number/SKU DYNJ907196B:  UDI/DI each 10193489946642, UDI/DI case 40193489946643, Lot Number: 23LBI665;  Medline Kit Number/SKU DYNJ907196C:  UDI/DI each 10198459479458, UDI/DI case 40198459479459, Lot Number: 26BBU055;  Medline Kit Number/SKU DYNJ907196C:  UDI/DI each 10198459479458, UDI/DI case 40198459479459, Lot Number: 26ABP733;  Medline Kit Number/SKU DYNJ907196C:  UDI/DI each 10198459479458, UDI/DI case 40198459479459, Lot Number: 25KBN484;  Medline Kit Number/SKU DYNJ907196C:  UDI/DI each 10198459479458, UDI/DI case 40198459479459, Lot Number: 25JBM722;  Medline Kit Number/SKU DYNJ908362F:  UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 26BLA610;  Medline Kit Number/SKU DYNJ908362F:  UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25LLA930;  Medline Kit Number/SKU DYNJ908362F:  UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25LLA516;  Medline Kit Number/SKU DYNJ908362F:  UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25LLA196;  Medline Kit Number/SKU DYNJ908362F:  UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25KLA552;  Medline Kit Number/SKU DYNJ908362F:  UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25FLA193;  Medline Kit Number/SKU DYNJ908362F:  UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25DLA774;  Medline Kit Number/SKU DYNJ908362F:  UDI/DI each 10198459308581, UDI/DI case 40198459308582, Lot Number: 25DLA488;  Medline Kit Number/SKU DYNJ909379:  UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23JBO029;  Medline Kit Number/SKU DYNJ909379:  UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23JBC433;  Medline Kit Number/SKU DYNJ909379:  UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23HBC019;  Medline Kit Number/SKU DYNJ909379:  UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23GBS064;  Medline Kit Number/SKU DYNJ909379:  UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23GBJ590;  Medline Kit Number/SKU DYNJ909379:  UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23CBK565;  Medline Kit Number/SKU DYNJ909379:  UDI/DI each 10195327321994, UDI/DI case 40195327321995, Lot Number: 23LBF500;  Medline Kit Number/SKU DYNJ909379A:  UDI/DI each 10195327580810, UDI/DI case 40195327580811, Lot Number: 24FBF086;  Medline Kit Number/SKU DYNJ909379A:  UDI/DI each 10195327580810, UDI/DI case 40195327580811, Lot Number: 24EBF609;  Medline Kit Number/SKU DYNJ909379A:  UDI/DI each 10195327580810, UDI/DI case 40195327580811, Lot Number: 24CBK778;  Medline Kit Number/SKU DYNJ909379A:  UDI/DI each 10195327580810, UDI/DI case 40195327580811, Lot Number: 24BBA312.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Worldwide distribution.

Recall record

Recalling firm: Medline Industries, LP
Product type: Devices
Recall number: Z-2016-2026
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Origin: Northfield, IL
Recall initiated: 2026-03-19

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2016-2026 · Source: openFDA enforcement.