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.
Check your package
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
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 7 Jan 2026 | Recall initiated by company | |
| 17 Feb 2026 | Classified by FDA | +41 days |
| 25 Feb 2026 | Published 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
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.
Questions about this recall
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
35 other products · FDA event 98329This product is part of a recall event; the main page for the event is Medline Convenience Kits: Kit Surg Onc Excision Breast recalled.
More recalls from Medline Industries
All 705| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits containing Healthmark Instrument recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Major Neuro Vch recalled by Medline Industries | Medline Industries | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,212| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |