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
FDA recall Z-2092-2026 — Medline Industries, LP is recalling 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 (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
openFDA drug & device enforcement (recall) reports
FDA recall Z-2092-2026: Medline Industries, LP is recalling 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
openFDA drug & device enforcement (recall) reports — U.S. FDA
A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.
FDA classified recall Z-2092-2026 as Class II
The FDA assigned this recall Class II: 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 official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
U.S. FDA recall classification (openFDA enforcement)
occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.
A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
a recorded enforcement action, not proof of harm or causation; not medical advice
occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.
Ongoing — the recall is still being carried out.
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.