Recall Z-1389-2026
Medline Industries, LP · initiated January 7, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medline Convenience Kits: 1) OR ARTERIOGRAM, Model Number: CDS985094F; 2) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153; 3) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4A; 4) KIT ACES INSERT PERCUTANEOUS T, Model Number: DYKMBNDL4B; 5) VEIN PROCEDURE KIT, Model Number: DYNDA2076C; 6) CARDIAC CATH PACK-LF, Model Number: DYNJ0150605AC; 7) CATH LAB PACK-LF, Model Number: DYNJ0648473Y; 8) NBMC CATH PACK-LF, Model Number: DYNJ0803367I; 9) ANGIO PACK-LF, Model Number: DYNJ0954970I; 10) CARDIAC CATH PACK, Model Number: DYNJ19946M; 11) CATH LAB PACK, Model Number: DYNJ30955I; 12) CATH LAB PACK, Model Number: DYNJ31773K; 13) CATH PACK-LF, Model Number: DYNJ33061D; 14) DB CCL OAKWOOD PACK-LF, Model Number: DYNJ33620D; 15) CARDIAC CATH PACK MRH-LF, Model Number: DYNJ35300M; 16) CATH LAB PK, Model Number: DYNJ35643C; 17) CARDIAC CATH PACK-LF, Model Number: DYNJ39066B; 18) CATH PACK-LF, Model Number: DYNJ43101C; 19) OR ANGIO PACK-LF, Model Number: DYNJ43415D; 20) OR ANGIO PACK-LF, Model Number: DYNJ43415F; 21) ANGIOPLASTY PACK, Model Number: DYNJ44700J; 22) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ44850J; 23) RADIOLOGICAL PACK, Model Number: DYNJ44889O; 24) CARDIAC CATH PACK, Model Number: DYNJ47370B; 25) ANGIOGRAPHY PACK, Model Number: DYNJ53129D; 26) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJ56772G; 27) DR. MOHINDRA PACK, Model Number: DYNJ57602G; 28) NE ENDO VASCULAR PACK, Model Number: DYNJ57940B; 29) CARDIAC CATH PACK - Q1, Model Number: DYNJ58048C; 30) OR ANGIO, Model Number: DYNJ59931B; 31) LPCH PERRY CATH PACK, Model Number: DYNJ67378C; 32) HOSPITAL REGIONAL DE CONCEPCIO, Model Number: DYNJ67918A; 33) CATH LAB PACK, Model Number: DYNJ68633; 34) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197B; 35) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197C; 36) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197D; 37) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197F; 38) STEWARD CATH LAB PACK GSS, Model Number: DYNJ81197G; 39) BASIC CARDIAC CATH PACK, Model Number: DYNJ81593B; 40) UMC EL PASO CATH PACK, Model Number: DYNJ83089; 41) DR. MOHINDRA PACK, Model Number: DYNJ83819A; 42) VZ VAS/ANG PACK, Model Number: DYNJ83981; 43) WCPN CARDIOLOGY PACK, Model Number: DYNJ84539; 44) CATH LAB, Model Number: DYNJ85511; 45) ANGIOGRAPHY DRAPE PACK, Model Number: DYNJT1520K; 46) ANGIOGRAPHY TRAY, Model Number: MNS9130; 47) CVC BUNDLE KIT, Model Number: ECVC6225A; 48) CVC 3L 7F 20CM VANTEX, Model Number: ECVC7265A
Codes / lots: 1) CDS985094F, UDI-DI: 10195327657642(each), 40195327657643(case), Lot Number: 25AMG933; 2) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 22ABO093; 3) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21LBJ748; 4) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21BBG516; 5) DYKMBNDL153, UDI-DI: 10193489478440(each), 40193489478441(case), Lot Number: 21ABI976; 6) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 22ALA279; 7) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21KLA100; 8) DYKMBNDL4A, UDI-DI: 10193489904512(each), 40193489904513(case), Lot Number: 21GLA930; 9) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 25ALA014; 10) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 24FLA816; 11) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 24CLA777; 12) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23KLA402; 13) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23JLA979; 14) DYKMBNDL4B, UDI-DI:…
Reason for recall
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA-determined cause: Under Investigation by firm
Action taken
An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Proxima Sterile Surgical Gowns, Packs, and Drapes. 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. Upon completion of the below actions, please destroy 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 response form. Website link: https://recalls.medline.com Recall Reference #: R-26-003 Recall Code: 3. Your account will receive credit once the response form is submitted. 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 request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Medline Kits containing Proxima Sterile Surgical Gowns and Drapes. 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-26-003-FGX1 Recall Code: 3. Upon receipt of your submitted response form,
Details
- Recall number
- Z-1389-2026
- Initiated
- January 7, 2026
- Posted by FDA
- February 17, 2026
- Product code
- OES – Cardiac Catheterization Kit
- Quantity
- 30958 units
- Distribution
- Worldwide distribution - US Nationwide.
- Recalling firm
- Medline Industries, LP, Northfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1384-2026 Class II | Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number: DYNJ0185290G; 2) OPEN…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1385-2026 Class II | Medline Convenience Kits: 1) KIT STC TRACHEOSTOMY, Model Number: DYKMBNDL55; 2) KIT STC…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1386-2026 Class II | Medline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number: DYNJ56436A; 2) SCC RF PAIN…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1387-2026 Class II | Medline Convenience Kits: 1) BASIC NERVE BLOCK TRAY W/LINEN, Model Number: PAIN0150CMedline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1388-2026 Class II | Medline Convenience Kits: 1) ENDO KIT W/SYRINGE, Model Number: DYKE1743; 2) BGMC…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1390-2026 Class II | Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1391-2026 Class II | Medline Convenience Kits: 1) PICC LINE TRAY, Model Number: 00-401993O; 2) CODE CART…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1392-2026 Class II | Medline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number: DYKMBNDL84A; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1393-2026 Class II | Medline Convenience Kits: 1) DENTAL PACK, Model Number: DYNDA3003Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1394-2026 Class II | Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1395-2026 Class II | Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1396-2026 Class II | Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1397-2026 Class II | Medline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1398-2026 Class II | Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1399-2026 Class II | Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1400-2026 Class II | Medline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2)…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1401-2026 Class II | Medline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1402-2026 Class II | Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1403-2026 Class II | Medline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806LMedline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1404-2026 Class II | Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1405-2026 Class II | Medline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200AMedline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1406-2026 Class II | Medline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118AMedline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1407-2026 Class II | Medline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031AMedline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1408-2026 Class II | Medline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945PMedline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1409-2026 Class II | Medline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1410-2026 Class II | Medline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343AMedline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1411-2026 Class II | Medline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1412-2026 Class II | Medline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1413-2026 Class II | Medline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |
| Z-1414-2026 Class II | Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL…Medline has identified issues related to calibration of the equipment used to sterilize and package the… | 01/07/2026Open, Classified |