Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4A;
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 07, 2026 |
| Reported | May 13, 2026 |
| Recalling firm | Medline Industries, LP |
| Country / region | United States IL |
Hazard
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.
Product description
Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Number:DYK1060193I; 4) KIT SURG ONC LAP DIAG/CV CATH, Model Number:DYKMBNDL153; 5) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4A; 6) KIT ACES INSERT PERCUTANEOUS T, Model Number:DYKMBNDL4B; 7) VEIN PROCEDURE KIT, Model Number:DYNDA2076C; 8) CARDIAC CATH PACK-LF, Model Number:DYNJ0150605AC; 9) CARDIAC CATH PACK-LF, Model Number:DYNJ0368386D; 10) CATH LAB PACK-LF, Model Number:DYNJ0648473Y; 11) NBMC CATH PACK-LF, Model Number:DYNJ0803367I; 12) RADIOLOGY PACK-LF, Model Number:DYNJ0928124C; 13) ANGIO PACK-LF, Model Number:DYNJ0954970I; 14) SPECIALS TRAY RADIOLOGY, Model Number:DYNJ16803D; 15) CARDIAC CATH PACK, Model Number:DYNJ19946M; 16) CATH LAB PACK, Model Number:DYNJ30955I; 17) CATH LAB PACK, Model Number:DYNJ31773K; 18) CATH PACK-LF, Model Number:DYNJ33061D; 19) DB CCL OAKWOOD PACK-LF, Model Number:DYNJ33620D; 20) CARDIAC CATH PACK MRH-LF, Model Number:DYNJ35300M; 21) CATH LAB PK, Model Number:DYNJ35643C; 22) CARDIAC CATH PACK-LF, Model Number:DYNJ39066B; 23) ANGIOGRAPHY PACK, Model Number:DYNJ42134G; 24) CATH PACK-LF, Model Number:DYNJ43101C; 25) OR ANGIO PACK-LF, Model Number:DYNJ43415D; 26) OR ANGIO PACK-LF, Model Number:DYNJ43415F; 27) ANGIOPLASTY PACK, Model Number:DYNJ44700J; 28) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJ44850J; 29) RADIOLOGICAL PACK, Model Number:DYNJ44889O; 30) CARDIAC CATH PACK, Model Number:DYNJ47370B; 31) ANGIOGRAPHY PACK, Model Number:DYNJ53129D; 32) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJ56772G; 33) DR. MOHINDRA PACK, Model Number:DYNJ57602G; 34) NE ENDO VASCULAR PACK, Model Number:DYNJ57940B; 35) CARDIAC CATH PACK - Q1, Model Number:DYNJ58048C; 36) OR ANGIO, Model Number:DYNJ59931B; 37) LPCH PERRY CATH PACK, Model Number:DYNJ67378C; 38) HOSPITAL REGIONAL DE CONCEPCIO, Model Number:DYNJ67918A; 39) CATH LAB PACK, Model Number:DYNJ68633; 40) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197B; 41) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197C; 42) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197D; 43) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197F; 44) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197G; 45) STEWARD CATH LAB PACK GSS, Model Number:DYNJ81197I; 46) BASIC CARDIAC CATH PACK, Model Number:DYNJ81593B; 47) CATH LAB PACK, Model Number:DYNJ83073; 48) UMC EL PASO CATH PACK, Model Number:DYNJ83089; 49) DR. MOHINDRA PACK, Model Number:DYNJ83819A; 50) VZ VAS/ANG PACK, Model Number:DYNJ83981; 51) WCPN CARDIOLOGY PACK, Model Number:DYNJ84539; 52) CATH LAB, Model Number:DYNJ85511; 53) CATH LAB, Model Number:DYNJ85511A; 54) ANGIOGRAPHY DRAPE PACK, Model Number:DYNJT1520K; 55) CVC BUNDLE KIT, Model Number:ECVC6225A; 56) CVC 3L 7F 20CM VANTEX, Model Number:ECVC7265A; 57) ANGIOGRAPHY TRAY, Model Number:MNS9130
Affected products
- Medline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR ARTERIOGRAM, Model Number:CDS985094F; 3) INTRAVASOR CATH KIT, Model Numb