Recall Z-1836-2026
Medline Industries, LP · initiated February 25, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS LHK BHS BAPTIST. LOUISVI, Model Number: 60022026; 3) MTO LEFT HEART KIT SUMMA BARBERT, Model Number: 60022673; 4) MTS LH KIT-UNIV OF MIAMI PG, Model Number: 60030817; 5) MTS LEFT HEART KIT SPRINGFIELD R, Model Number: 60031245; 6) MTS PERIPHERAL KIT SPRINGFIELD R, Model Number: 60031247; 7) MTS LEFT HEART KIT-COLISEUM MED, Model Number: 60031928; 8) MTS LEFT HEART KIT -2-CALIFORNIA, Model Number: 60033011; 9) MTS LEFT HEART KIT JOHN MUIR CON, Model Number: 60040273; 10) MTS EP MANIFOLD KIT TEXAS HLTH P, Model Number: 60041268; 11) MTS 3V MANIFOLD KIT-SPARROW HOSP, Model Number: 60050097; 12) MTS LEFT HEART KIT FORT SANDERS, Model Number: 60060387; 13) MTS LEFT HEART KIT-GOOD SAMARITA, Model Number: 60070435; 14) DBD-MTS ANGIO KIT-MOUNT HOOD MED, Model Number: 60070521; 15) MTS LFT HRT KIT-GRAND VIEW PG, Model Number: 60071743; 16) MTS CUSTOM MANIFOLD KIT-INGALLS, Model Number: 60090078; 17) MTS CATH LAB KIT - HEARTLAND PG, Model Number: 60090542; 18) MTS LEFT HEART KIT-W.C.A PG, Model Number: 60100071; 19) MTS MANIFOLD KIT-GENESYS REG MED, Model Number: 60100254; 20) MTS 4V W/PRO STA-ST.JOHNS REG ME, Model Number: 60100439; 21) MTS LEFT HEART KIT JEANES HOSPIT, Model Number: 60101773; 22) MTS LEFT HEART KIT-ST. MARYS OF, Model Number: 60131099; 23) DBD-MTS LEFT HEART KIT-LEHIGH VA, Model Number: 60132653; 24) MTS LEFT HEART KIT (3V DT WASTE), Model Number: 60138326; 25) MTS LF HRT KIT-PRESBYTERIAN UNIV, Model Number: 60160148; 26) MTS LEFT HEART KIT-PENINSULA REG, Model Number: 60160428; 27) MTS LEFT HEART KIT BARNES ST.PET, Model Number: 60161135; 28) MTO OR ENDO KIT - PARK RIDGE HOS, Model Number: 60163618; 29) MTS 3V W/DT-CORPUS CHRISTI M.C., Model Number: 60181531; 30) MTS 3V PERC MANIFOLD KIT WEST. A, Model Number: 60182137; 31) MTO CATH KIT PAMPA REGIONAL MED, Model Number: 60182661; 32) MTO HOPKINS LEFT HEART HOWARD CO, Model Number: 60183662; 33) MTS-CARDIOLOGY KIT-HARLINGEN MED, Model Number: 60184001; 34) MTS PERCEPTOR KIT METHODIST. RIC, Model Number: 60185432; 35) MTS LEFT HEART KIT SADDLEBACK ME, Model Number: 60191312; 36) MTS-CARD MAN KIT MARIAN MED CENT, Model Number: 60194273; 37) LEFT HEART KIT SOUTHERN HILLS HO, Model Number: 60195202; 38) MTS DR KHAIRALLAH LEFT HEART KIT, Model Number: 60200189; 39) MTS,4V,DIAG,KIT UNIV OF CONNECTICUT, Model Number: 60210014; 40) MTO L/H KIT-UNIV OF CLEVELAND -, Model Number: 60210047; 41) MTS LEFT HEART KIT-BAPTIST HLTH, Model Number: 60230503; 42) MTS CAN KIT ACCESSOIRE DIAGNOSTI, Model Number: 60700527; 43) MTS LEFT HEART W/SYRINGE-EMORY U, Model Number: 600503712; 44) MTS ACCESSORY KIT SAINT JOSEPH L, Model Number: 601010412; 45) MTS 3 PORT WHITE KIT LEESBURG RE, Model Number: 601222712; 46) MTS PEDS LFT RT HRT-SUNRISE HO, Model Number: 601905414; 47) MTS LHK ST. LOUIS CARDIO INST, Model Number: 606119072; 48) LHK CENTURA HLTH CORP (ST. ANTHO, Model Number: 6010030361; 49) MTS LHK CHAMPLAIN VALLEY, Model Number: 6010128411; 50) MTS LHK VANDERBILT COFFEE HARTON, Model Number: 6019705921; 51) DBD-LHK EPIC SURGERY CENTER LLC, Model Number: 6020410581; 52) DBD-MTS LHK MS HEALTHCARE MGMT, Model Number: 6061073001; 53) LHK - WESLEY MEDICAL CENTER, Model Number: 6010088152A; 54) IR ANGIOGRAPHY PACK-LF, Model Number: DYNJVB1077D; 55) RADIOLOGY SPECIALS TRAY, Model Number: DYNJVB1302B; 56) ANGIO LEFT HEART PACK, Model Number: DYNJ40632D; 57) ANGIO RIGHT HEART PACK, Model Number: DYNJ40633C; 58) ANGIO TRAY, Model Number: DYNJ43278C; 59) CARDIAC LEG PACK, Model Number: DYNJ44065C; 60) EP PACK, Model Number: DYNJ55512A; 61) VASCULAR PACK, Model Number: DYNJ58522A; 62) PERIPHERAL CATH, Model Number: DYNJ59220C; 63) CARDIAC CATH - NO SYR, Model Number: DYNJ62409A; 64) C V MINOR PACK, Model Number: DYNJ64862B; 65) ENDOVASCULAR PACK, Model Number: DYNJ65926
Codes / lots: 1) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 183372; 2) 60021775, UDI-DI: 10193489041385(each), 20193489041382(case), Lot Number: 185190; 3) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 106008; 4) 60022026, UDI-DI: 10193489087253(each), 20193489087250(case), Lot Number: 117378; 5) 60022673, UDI-DI: 10193489041538(each), 20193489041535(case), Lot Number: 176180; 6) 60030817, UDI-DI: 10193489041972(each), 20193489041979(case), Lot Number: 185193; 7) 60031245, UDI-DI: 10193489042214(each), 20193489042211(case), Lot Number: 183374; 8) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 174370; 9) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 184424; 10) 60031247, UDI-DI: 10193489042238(each), 20193489042235(case), Lot Number: 185080; 11) 60031928, UDI-DI: 10193489042276(each), 20193489042273(case), Lot Number: 185195; 12) 60033011, UDI-DI: 10193489042429(each), 20193489042426(case), Lot Number: 181365; 13) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 179872; 14) 60040273, UDI-DI: 10193489042832(each), 20193489042839(case), Lot Number: 183375; 15)…
Reason for recall
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
FDA-determined cause: No Marketing Application
Action taken
An URGENT MEDICAL DEVICE RECALL dated 2/25/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and lot number(s) listed in the recall portal. Quarantine all affected product. 2. Complete your response form. List the quantity of affected product you have in inventory on the form. Even if you do not have any affected product, submit the form to Website link: https://recalls.medline.com Recall Reference #: R-26-020-FGX1 Recall Code: 3. When we receive your response form, we will send over-labels via FedEx overnight to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. 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. Include your customers quantities on your response form. When we receive your response form, we will send over-labels to provide to your customers. Any questions? Contact the Recall Department at 866-359-1704 or recalls@medline.com. *** An Urgent Medical Device Recall notification letter dated 3/2/26 was sent to customers. This is a follow-up to a Medline notification you may have received on February 25, 2026. New item numbers and lot numbers have been included with this communication. Recipients receiving this notification for the first time were not affected by the original notification. REQUIRED ACTIONS: same as for 2/25/26 letter
Details
- Recall number
- Z-1836-2026
- Initiated
- February 25, 2026
- Posted by FDA
- April 17, 2026
- Product code
- OEZ – Cardiovascular Procedure Kit
- Quantity
- 19189 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1829-2026 Class II | Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1830-2026 Class II | Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1831-2026 Class II | Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2)…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1832-2026 Class II | Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517DThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1833-2026 Class II | Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1834-2026 Class II | Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1835-2026 Class II | Medline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number:…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1837-2026 Class II | Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648AThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1838-2026 Class II | Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543AThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1839-2026 Class II | Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1840-2026 Class II | Medline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027YThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1841-2026 Class II | Medline Kits: 1) BREAST PACK, Model Number: DYNJ66777DThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1842-2026 Class II | Medline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1843-2026 Class II | Medline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1844-2026 Class II | Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1845-2026 Class II | Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813DThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1846-2026 Class II | Medline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257FThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1847-2026 Class II | Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1848-2026 Class II | Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254BThe 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1849-2026 Class II | Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF, Model Number: DYNJ32841F; 2) CRANIOTOMY…The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |
| Z-1850-2026 Class II | Medline Kits: 1) ARTHROSCOPY PACK, Model Number: DYNJ82440The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have… | 02/25/2026Open, Classified |