CLASS II ONGOING Device recall · Reported 25 Feb 2026 · FDA Enforcement Report

Medline Convenience Kits: OR Arteriogram recalled by Medline Industries

Medline Industries is recalling Medline Convenience Kits: OR Arteriogram, distributed nationwide in the US. The recall was initiated on 7 Jan 2026 and the FDA has classified it as Class II.

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Lot, batch or date codes1) 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: 10195327200589(each), 40195327200580(case), Lot Number: 23ILA268; 15) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23HLA316; 16) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA710; 17) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA176; 18) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23BLA583; 19) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 22HLB260; 20) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24LMB205; 21) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24KMC111; 22) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24HMD928; 23) DYNJ0150605AC, UDI-DI: 10198459106422(each), 40198459106423(case), Lot Number: 24IMB736; 24) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25EBR586; 25) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25CBO084; 26) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25BBT175; 27) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25ABH209; 28) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24LBE715; 29) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24IBS786; 30) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24HBQ060; 31) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24GBT979; 32) DYNJ0803367I, UDI-DI: 10195327461027(each), 40195327461028(case), Lot Number: 23IMC122; 33) DYNJ0954970I, UDI-DI: 10198459297571(each), 40198459297572(case), Lot Number: 25FMJ515; 34) DYNJ19946M, UDI-DI: 10193489907933(each), 40193489907934(case), Lot Number: 23HBO857; 35) DYNJ30955I, UDI-DI: 10195327428051(each), 40195327428052(case), Lot Number: 23GBN513; 36) DYNJ31773K, UDI-DI: 10195327245856(each), 40195327245857(case), Lot Number: 23ABB938; 37) DYNJ33061D, UDI-DI: 10193489841428(each), 40193489841429(case), Lot Number: 21CBI315; 38) DYNJ33620D, UDI-DI: 10889942677832(each), 40889942677833(case), Lot Number: 21ADA464; 39) DYNJ35300M, UDI-DI: 10195327101169(each), 40195327101160(case), Lot Number: 22JMB302; 40) DYNJ35643C, UDI-DI: 10195327111946(each), 40195327111947(case), Lot Number: 23CBI301; 41) DYNJ39066B, UDI-DI: 10193489937268(each), 40193489937269(case), Lot Number: 23HMG433; 42) DYNJ43101C, UDI-DI: 10888277737327(each), 40888277737328(case), Lot Number: 21ADA535; 43) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 24CBG256; 44) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 24ABI910; 45) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 23IBP533; 46) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 25EBF775; 47) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24LBQ306; 48) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24KBR090; 49) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24IBU874; 50) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24HBM254; 51) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24GBV382; 52) DYNJ44700J, UDI-DI: 10195327277413(each), 40195327277414(case), Lot Number: 25JDA679; 53) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23IBB504; 54) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23GBP204; 55) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23FBF258; 56) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23EBG893; 57) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23DBI845; 58) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23BBD736; 59) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23ABR589; 60) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22OBA581; 61) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22LBG760; 62) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22JBY064; 63) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22JBC588; 64) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22IBT510; 65) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22HBM547; 66) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22FBN577; 67) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22EBP030; 68) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22CBV346; 69) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22ABK883; 70) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22ABI539; 71) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 21KBO116; 72) DYNJ44889O, UDI-DI: 10193489979411(each), 40193489979412(case), Lot Number: 22CMA383; 73) DYNJ44889O, UDI-DI: 10193489979411(each), 40193489979412(case), Lot Number: 22AME756; 74) DYNJ47370B, UDI-DI: 10889942975723(each), 40889942975724(case), Lot Number: 22LBP706; 75) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23HMH791; 76) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23GMI002; 77) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23FME772; 78) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23EME724; 79) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23DMF448; 80) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23CMB279; 81) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23BMC700; 82) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22LMD047; 83) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22KMC442; 84) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22JME805; 85) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22IMG735; 86) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22GMI134; 87) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22CMH914; 88) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22BMG182; 89) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22AMD580; 90) DYNJ57602G, UDI-DI: 10195327338169(each), 40195327338160(case), Lot Number: 23BBK044; 91) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 23KBB465; 92) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25KMD960; 93) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25JME465; 94) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25AMG240; 95) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24KMD474; 96) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24JMJ426; 97) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24HMF813; 98) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24GMH576; 99) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24EMH576; 100) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24DMG251; 101) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24DMC509; 102) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24CMG318; 103) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24CMF744; 104) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23LMD057; 105) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23KMH102; 106) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23IMD765; 107) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23GMF491; 108) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23FME284; 109) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23DMI350; 110) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23BME160; 111) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23AMI769; 112) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 22LMA967; 113) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23GBC772; 114) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23EBN753; 115) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23CBU118; 116) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23ABL095; 117) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22LBA917; 118) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22KBH299; 119) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22HBI355; 120) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22FBU003; 121) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22DBS611; 122) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22DBM388; 123) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22BBX590; 124) DYNJ67378C, UDI-DI: 10195327697501(each), 40195327697502(case), Lot Number: 24HME465; 125) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22OBG779; 126) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22CBZ027; 127) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22CBZ026; 128) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 21LBP804; 129) DYNJ68633, UDI-DI: 10193489837667(each), 40193489837668(case), Lot Number: 21BBQ520; 130) DYNJ81197B, UDI-DI: 10195327427818(each), 40195327427819(case), Lot Number: 23GBC445; 131) DYNJ81197B, UDI-DI: 10195327427818(each), 40195327427819(case), Lot Number: 23FBA862; 132) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23JBR165; 133) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23JBF780; 134) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23IBT017; 135) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23HBZ547; 136) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23GBJ036; 137) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24JBE696; 138) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24IBL386; 139) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24HBK118; 140) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24GBA095; 141) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24EBU925; 142) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24DBF346; 143) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24ABW070; 144) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25EBR556; 145) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25DBT193; 146) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25CBG703; 147) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 24LBU027; 148) DYNJ81197G, UDI-DI: 10198459369179(each), 40198459369170(case), Lot Number: 25FBT968; 149) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23IBJ841; 150) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23GBO156; 151) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23EBT723; 152) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23IMB693; 153) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23GMD133; 154) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23FMC409; 155) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23EMF492; 156) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23DMD375; 157) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23DMA913; 158) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23BMB766; 159) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 22JMI325; 160) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23HBX967; 161) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23FBV261; 162) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23FBJ743; 163) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23EBU525; 164) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23CBS129; 165) DYNJ83981, UDI-DI: 10195327324124(each), 40195327324125(case), Lot Number: 23CMI086; 166) DYNJ84539, UDI-DI: 10195327375706(each), 40195327375707(case), Lot Number: 23FMH066; 167) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 25EBR907; 168) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24LBK715; 169) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24KBR659; 170) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24IBI836
Quantity recalled30958 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1389-2026
FDA event ID
98329
Recalling firm
Medline Industries, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
7 Jan 2026
FDA classified
17 Feb 2026
Reported
25 Feb 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Foreign Material

Timeline

7 Jan 2026Recall initiated by company
17 Feb 2026Classified by FDA+41 days
25 Feb 2026Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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

Where it was distributed

Worldwide distribution - US Nationwide.

Nationwide

Questions about this recall

Is Medline Convenience Kits: OR Arteriogram recalled?

Yes. Medline Industries recalled Medline Convenience Kits: OR Arteriogram on 7 Jan 2026. The recall is Class II and its status is Ongoing. Recall number Z-1389-2026.

Why was it recalled?

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.

Which lots are affected?

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: 10195327200589(each), 40195327200580(case), Lot Number: 23ILA268; 15) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23HLA316; 16) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA710; 17) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23GLA176; 18) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 23BLA583; 19) DYKMBNDL4B, UDI-DI: 10195327200589(each), 40195327200580(case), Lot Number: 22HLB260; 20) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24LMB205; 21) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24KMC111; 22) DYNDA2076C, UDI-DI: 10198459001208(each), 40198459001209(case), Lot Number: 24HMD928; 23) DYNJ0150605AC, UDI-DI: 10198459106422(each), 40198459106423(case), Lot Number: 24IMB736; 24) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25EBR586; 25) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25CBO084; 26) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25BBT175; 27) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 25ABH209; 28) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24LBE715; 29) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24IBS786; 30) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24HBQ060; 31) DYNJ0648473Y, UDI-DI: 10195327647834(each), 40195327647835(case), Lot Number: 24GBT979; 32) DYNJ0803367I, UDI-DI: 10195327461027(each), 40195327461028(case), Lot Number: 23IMC122; 33) DYNJ0954970I, UDI-DI: 10198459297571(each), 40198459297572(case), Lot Number: 25FMJ515; 34) DYNJ19946M, UDI-DI: 10193489907933(each), 40193489907934(case), Lot Number: 23HBO857; 35) DYNJ30955I, UDI-DI: 10195327428051(each), 40195327428052(case), Lot Number: 23GBN513; 36) DYNJ31773K, UDI-DI: 10195327245856(each), 40195327245857(case), Lot Number: 23ABB938; 37) DYNJ33061D, UDI-DI: 10193489841428(each), 40193489841429(case), Lot Number: 21CBI315; 38) DYNJ33620D, UDI-DI: 10889942677832(each), 40889942677833(case), Lot Number: 21ADA464; 39) DYNJ35300M, UDI-DI: 10195327101169(each), 40195327101160(case), Lot Number: 22JMB302; 40) DYNJ35643C, UDI-DI: 10195327111946(each), 40195327111947(case), Lot Number: 23CBI301; 41) DYNJ39066B, UDI-DI: 10193489937268(each), 40193489937269(case), Lot Number: 23HMG433; 42) DYNJ43101C, UDI-DI: 10888277737327(each), 40888277737328(case), Lot Number: 21ADA535; 43) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 24CBG256; 44) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 24ABI910; 45) DYNJ43415D, UDI-DI: 10195327512873(each), 40195327512874(case), Lot Number: 23IBP533; 46) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 25EBF775; 47) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24LBQ306; 48) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24KBR090; 49) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24IBU874; 50) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24HBM254; 51) DYNJ43415F, UDI-DI: 10195327674731(each), 40195327674732(case), Lot Number: 24GBV382; 52) DYNJ44700J, UDI-DI: 10195327277413(each), 40195327277414(case), Lot Number: 25JDA679; 53) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23IBB504; 54) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23GBP204; 55) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23FBF258; 56) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23EBG893; 57) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23DBI845; 58) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23BBD736; 59) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 23ABR589; 60) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22OBA581; 61) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22LBG760; 62) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22JBY064; 63) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22JBC588; 64) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22IBT510; 65) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22HBM547; 66) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22FBN577; 67) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22EBP030; 68) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22CBV346; 69) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22ABK883; 70) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 22ABI539; 71) DYNJ44850J, UDI-DI: 10193489976342(each), 40193489976343(case), Lot Number: 21KBO116; 72) DYNJ44889O, UDI-DI: 10193489979411(each), 40193489979412(case), Lot Number: 22CMA383; 73) DYNJ44889O, UDI-DI: 10193489979411(each), 40193489979412(case), Lot Number: 22AME756; 74) DYNJ47370B, UDI-DI: 10889942975723(each), 40889942975724(case), Lot Number: 22LBP706; 75) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23HMH791; 76) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23GMI002; 77) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23FME772; 78) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23EME724; 79) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23DMF448; 80) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23CMB279; 81) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 23BMC700; 82) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22LMD047; 83) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22KMC442; 84) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22JME805; 85) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22IMG735; 86) DYNJ53129D, UDI-DI: 10195327107222(each), 40195327107223(case), Lot Number: 22GMI134; 87) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22CMH914; 88) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22BMG182; 89) DYNJ56772G, UDI-DI: 10195327054069(each), 40195327054060(case), Lot Number: 22AMD580; 90) DYNJ57602G, UDI-DI: 10195327338169(each), 40195327338160(case), Lot Number: 23BBK044; 91) DYNJ57940B, UDI-DI: 10195327450762(each), 40195327450763(case), Lot Number: 23KBB465; 92) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25KMD960; 93) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25JME465; 94) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 25AMG240; 95) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24KMD474; 96) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24JMJ426; 97) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24HMF813; 98) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24GMH576; 99) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24EMH576; 100) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24DMG251; 101) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24DMC509; 102) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24CMG318; 103) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 24CMF744; 104) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23LMD057; 105) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23KMH102; 106) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23IMD765; 107) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23GMF491; 108) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23FME284; 109) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23DMI350; 110) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23BME160; 111) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 23AMI769; 112) DYNJ58048C, UDI-DI: 10195327285098(each), 40195327285099(case), Lot Number: 22LMA967; 113) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23GBC772; 114) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23EBN753; 115) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23CBU118; 116) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 23ABL095; 117) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22LBA917; 118) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22KBH299; 119) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22HBI355; 120) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22FBU003; 121) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22DBS611; 122) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22DBM388; 123) DYNJ59931B, UDI-DI: 10195327106546(each), 40195327106547(case), Lot Number: 22BBX590; 124) DYNJ67378C, UDI-DI: 10195327697501(each), 40195327697502(case), Lot Number: 24HME465; 125) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22OBG779; 126) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22CBZ027; 127) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 22CBZ026; 128) DYNJ67918A, UDI-DI: 10195327042776(each), 40195327042777(case), Lot Number: 21LBP804; 129) DYNJ68633, UDI-DI: 10193489837667(each), 40193489837668(case), Lot Number: 21BBQ520; 130) DYNJ81197B, UDI-DI: 10195327427818(each), 40195327427819(case), Lot Number: 23GBC445; 131) DYNJ81197B, UDI-DI: 10195327427818(each), 40195327427819(case), Lot Number: 23FBA862; 132) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23JBR165; 133) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23JBF780; 134) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23IBT017; 135) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23HBZ547; 136) DYNJ81197C, UDI-DI: 10195327460839(each), 40195327460830(case), Lot Number: 23GBJ036; 137) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24JBE696; 138) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24IBL386; 139) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24HBK118; 140) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24GBA095; 141) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24EBU925; 142) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24DBF346; 143) DYNJ81197D, UDI-DI: 10195327590093(each), 40195327590094(case), Lot Number: 24ABW070; 144) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25EBR556; 145) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25DBT193; 146) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 25CBG703; 147) DYNJ81197F, UDI-DI: 10198459225000(each), 40198459225001(case), Lot Number: 24LBU027; 148) DYNJ81197G, UDI-DI: 10198459369179(each), 40198459369170(case), Lot Number: 25FBT968; 149) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23IBJ841; 150) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23GBO156; 151) DYNJ81593B, UDI-DI: 10195327405298(each), 40195327405299(case), Lot Number: 23EBT723; 152) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23IMB693; 153) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23GMD133; 154) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23FMC409; 155) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23EMF492; 156) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23DMD375; 157) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23DMA913; 158) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 23BMB766; 159) DYNJ83089, UDI-DI: 10195327230838(each), 40195327230839(case), Lot Number: 22JMI325; 160) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23HBX967; 161) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23FBV261; 162) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23FBJ743; 163) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23EBU525; 164) DYNJ83819A, UDI-DI: 10195327338176(each), 40195327338177(case), Lot Number: 23CBS129; 165) DYNJ83981, UDI-DI: 10195327324124(each), 40195327324125(case), Lot Number: 23CMI086; 166) DYNJ84539, UDI-DI: 10195327375706(each), 40195327375707(case), Lot Number: 23FMH066; 167) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 25EBR907; 168) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24LBK715; 169) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24KBR659; 170) DYNJ85511, UDI-DI: 10195327511302(each), 40195327511303(case), Lot Number: 24IBI836

Where was it sold?

Worldwide distribution - US Nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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