CLASS II ONGOING Device recall · Reported 13 May 2026 · FDA Enforcement Report
See RES for full list recalled by Medline Industries
Medline Industries is recalling See RES for full list, 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-2097-2026
- FDA event ID
- 98642
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Jan 2026
- FDA classified
- 7 May 2026
- Reported
- 13 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hearing Aids
Timeline
| 7 Jan 2026 | Recall initiated by company | |
| 7 May 2026 | Classified by FDA | +120 days |
| 13 May 2026 | Published in enforcement report | +6 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
See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B;
Where it was distributed
Worldwide - US Nationwide distribution.
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) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21HBO921; 2) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21IBD399; 3) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22FBX804; 4) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22GBE731; 5) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22JBW315; 6) CDS983782C, UDI-DI: 10193489592047(each), 40193489592048(case), Lot Number: 21DKA756; 7) DYKE1456D, UDI-DI: 10195327639938(each), 40195327639939(case), Lot Number: 24CBK289; 8) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24ALA266; 9) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24DLA606; 10) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25CLB002; 11) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25DLB145; 12) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25FLA904; 13) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25HLA345; 14) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21ABK323; 15) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21BBG062; 16) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21CBD340; 17) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21DBJ855; 18) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21FBO537; 19) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21FBS478; 20) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21GBE737; 21) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21HBF494; 22) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21IBP624; 23) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21JBA009; 24) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21JBB014; 25) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22ABG015; 26) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22BBA231; 27) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22CBX230; 28) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22DBL428; 29) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22EBS812; 30) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22FBT038; 31) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22GBH498; 32) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 22IBU647; 33) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 22KBH786; 34) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23ABQ109; 35) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23DBM060; 36) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23EBS366; 37) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23FBG212; 38) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23HBT877; 39) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23HBV381; 40) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23JBQ487; 41) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23JBT911; 42) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24ABL113; 43) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24DBV609; 44) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24EBF125; 45) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24GBD477; 46) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24GBR935; 47) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24HBU706; 48) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24KBJ157; 49) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25ABK769; 50) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25BBM402; 51) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25DBQ008; 52) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25EBH975; 53) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25GBX739; 54) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21ABH824; 55) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21BBP836; 56) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21FBQ554; 57) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 21LBY299; 58) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 22BBS429; 59) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 22EBO543; 60) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 22KBK464; 61) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 22LBI002; 62) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 23ABH675; 63) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 23JBN238; 64) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24CBA389; 65) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24DBB691; 66) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24EBP260; 67) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 25LBM606; 68) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21ABP337; 69) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21BBG851; 70) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBF521; 71) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBH559; 72) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBM511; 73) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBS041; 74) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBT411; 75) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 22JLB001; 76) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 22KLA452; 77) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 23BLA884; 78) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23CLA769; 79) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23DLA495; 80) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23HLA624; 81) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23ILA756; 82) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23JLA058; 83) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23KLA620; 84) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23LLA422; 85) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24FLA349; 86) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24GLA055; 87) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24HLA924; 88) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24HLB156; 89) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24ILA560; 90) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24JLA055; 91) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25BLA837; 92) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25CLA312; 93) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25DLA251; 94) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25FLA791; 95) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25FLA924; 96) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA179; 97) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA232; 98) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA843; 99) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25ILA035; 100) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25ILA386; 101) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21ABJ862; 102) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21ABJ985; 103) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21BBL111; 104) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21CBS031; 105) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21DBK216; 106) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21EBM706; 107) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21FBT798; 108) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 21IBD784; 109) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 21JBJ743; 110) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22EBO633; 111) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22EBQ053; 112) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22FBE193; 113) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22GBF522; 114) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22GBQ602; 115) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22HBP925; 116) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 22IBL167; 117) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 22JBW957; 118) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23BBS356; 119) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23DBP706; 120) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23EBB247; 121) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23EBT500; 122) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23FBP266; 123) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23HBH678; 124) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23HBX217; 125) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23IBA611; 126) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23LBP166; 127) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24ABH039; 128) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24ABK306; 129) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24CBR483; 130) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24DBU451; 131) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24EBU213; 132) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24GBC830; 133) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24GBP188; 134) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 22JBG017; 135) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 22JBQ673; 136) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 22LBN128; 137) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 23LBF184; 138) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 24BBT350; 139) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 24CBD159; 140) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 24DBD514; 141) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24DBR155; 142) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24FBG015; 143) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24HBH734; 144) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24IBO509; 145) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24KBT017; 146) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24LBT153; 147) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25ABH117; 148) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25CBR258; 149) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25JBF754; 150) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25LBI754; 151) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 22JBD610; 152) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 22JBW066; 153) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 22LBR829; 154) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 23ABK217; 155) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 23CBJ801; 156) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 23CBN843; 157) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24BBJ842; 158) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24BBL266; 159) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24DBS395; 160) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24EBF126; 161) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24EBU598; 162) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24GBN944; 163) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24GBU190; 164) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24JBL602; 165) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24JBX567; 166) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25ABH118; 167) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25ABS392; 168) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25CBI877; 169) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25EBK536; 170) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25EBU506; 171) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25FBT988; 172) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25HBT644; 173) DYKMBNDL88C, UDI-DI: 10198459584886(each), 40198459584887(case), Lot Number: 25LBP011; 174) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24DBR908; 175) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24GBH580; 176) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24HBJ497; 177) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24HBN645; 178) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24IBQ080; 179) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24KBA441; 180) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 25GBG516; 181) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 25HBP413; 182) DYNJ01831I, UDI-DI: 10889942572502(each), 40889942572503(case), Lot Number: 21EMA909; 183) DYNJ0387711F, UDI-DI: 10198459005893(each), 40198459005894(case), Lot Number: 24HMA304; 184) DYNJ0855090P, UDI-DI: 10198459605826(each), 40198459605827(case), Lot Number: 25LMA083; 185) DYNJ17005I, UDI-DI: 10193489241860(each), 40193489241861(case), Lot Number: 23HBV662; 186) DYNJ26780I, UDI-DI: 10193489238822(each), 40193489238823(case), Lot Number: 23GBP197; 187) DYNJ27320V, UDI-DI: 10195327104719(each), 40195327104710(case), Lot Number: 22LBQ654; 188) DYNJ30604R, UDI-DI: 10195327514198(each), 40195327514199(case), Lot Number: 23LBU616; 189) DYNJ32060C, UDI-DI: 10884389637265(each), 40884389637266(case), Lot Number: 22LBS348; 190) DYNJ32809I, UDI-DI: 10193489448795(each), 40193489448796(case), Lot Number: 22IBP091; 191) DYNJ33585F, UDI-DI: 10195327469528(each), 40195327469529(case), Lot Number: 23JDA407; 192) DYNJ33586D, UDI-DI: 10195327223366(each), 40195327223367(case), Lot Number: 23JDA459; 193) DYNJ41169, UDI-DI: 10884389906699(each), 40884389906690(case), Lot Number: 22LBR515; 194) DYNJ45175B, UDI-DI: 10889942485215(each), 40889942485216(case), Lot Number: 24HLA032; 195) DYNJ47481C, UDI-DI: 10889942544028(each), 40889942544029(case), Lot Number: 21BBP023; 196) DYNJ47882F, UDI-DI: 10195327319472(each), 40195327319473(case), Lot Number: 23HME434; 197) DYNJ48401B, UDI-DI: 10195327173098(each), 40195327173099(case), Lot Number: 23CBR177; 198) DYNJ48401B, UDI-DI: 10195327173098(each), 40195327173099(case), Lot Number: 23CBT206; 199) DYNJ48401B, UDI-DI: 10195327173098(each), 40195327173099(case), Lot Number: 23GBA277; 200) DYNJ48401B, UDI-DI: 10195327173098(each), 40195327173099(case), Lot Number: 23HBJ541; 201) DYNJ48401B, UDI-DI: 10195327173098(each), 40195327173099(case), Lot Number: 23JBA900; 202) DYNJ48401B, UDI-DI: 10195327173098(each), 40195327173099(case), Lot Number: 23LBO079; 203) DYNJ48401B, UDI-DI: 10195327173098(each), 40195327173099(case), Lot Number: 23LBS232; 204) DYNJ48401B, UDI-DI: 10195327173098(each), 40195327173099(case), Lot Number: 24ABR658; 205) DYNJ48401B, UDI-DI: 10195327173098(each), 40195327173099(case), Lot Number: 24DBG199; 206) DYNJ48401C, UDI-DI: 10198459175749(each), 40198459175740(case), Lot Number: 25ABD063; 207) DYNJ48401C, UDI-DI: 10198459175749(each), 40198459175740(case), Lot Number: 25BBT722; 208) DYNJ48401C, UDI-DI: 10198459175749(each), 40198459175740(case), Lot Number: 25CBM527; 209) DYNJ48401C, UDI-DI: 10198459175749(each), 40198459175740(case), Lot Number: 25EBQ061; 210) DYNJ48401C, UDI-DI: 10198459175749(each), 40198459175740(case), Lot Number: 25FBS319; 211) DYNJ48401C, UDI-DI: 10198459175749(each), 40198459175740(case), Lot Number: 25HBA711; 212) DYNJ51934A, UDI-DI: 10193489584776(each), 40193489584777(case), Lot Number: 23HMG725; 213) DYNJ52916A, UDI-DI: 10195327311735(each), 40195327311736(case), Lot Number: 24GMK024; 214) DYNJ54721F, UDI-DI: 10195327021290(each), 40195327021291(case), Lot Number: 23EBG645; 215) DYNJ54757B, UDI-DI: 10195327021085(each), 40195327021086(case), Lot Number: 23FBQ117; 216) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 24IBV894; 217) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 24LBN788; 218) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 25BBM674; 219) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 25DBB366; 220) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 25EBB513; 221) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 25EBV663; 222) DYNJ54964B, UDI-DI: 10198459428814(each), 40198459428815(case), Lot Number: 25HBR203; 223) DYNJ54964B, UDI-DI: 10198459428814(each), 40198459428815(case), Lot Number: 25KBH303; 224) DYNJ55350G, UDI-DI: 10195327173753(each), 40195327173754(case), Lot Number: 24CBT148; 225) DYNJ56840B, UDI-DI: 10193489416077(each), 40193489416078(case), Lot Number: 21IBQ696; 226) DYNJ56840B, UDI-DI: 10193489416077(each), 40193489416078(case), Lot Number: 21IBQ699; 227) DYNJ56840B, UDI-DI: 10193489416077(each), 40193489416078(case), Lot Number: 22GBJ777; 228) DYNJ57200C, UDI-DI: 10198459306754(each), 40198459306755(case), Lot Number: 25DMF322; 229) DYNJ57200C, UDI-DI: 10198459306754(each), 40198459306755(case), Lot Number: 25EMA242; 230) DYNJ57688F, UDI-DI: 10195327034610(each), 40195327034611(case), Lot Number: 22HMH769; 231) DYNJ61286C, UDI-DI: 10195327416263(each), 40195327416264(case), Lot Number: 24BBT395; 232) DYNJ61393A, UDI-DI: 10193489444179(each), 40193489444170(case), Lot Number: 23CMB523; 233) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 23HBC470; 234) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 23LBP950; 235) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 24BBI869; 236) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 24BBK459; 237) DYNJ62093B, UDI-DI: 10193489969351(each), 40193489969352(case), Lot Number: 23ABE410; 238) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24ABK239; 239) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24DBV691; 240) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24EBS530; 241) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24GBM556; 242) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24HBO119; 243) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24KBS794; 244) DYNJ66509A, UDI-DI: 10193489462708(each), 40193489462709(case), Lot Number: 24HMA316; 245) DYNJ67208, UDI-DI: 10193489391671(each), 40193489391672(case), Lot Number: 20XBA769; 246) DYNJ67328B, UDI-DI: 10195327271503(each), 40195327271504(case), Lot Number: 23HMD036; 247) DYNJ69746B, UDI-DI: 10195327475222(each), 40195327475223(case), Lot Number: 24JLA247; 248) DYNJ81280A, UDI-DI: 10195327491284(each), 40195327491285(case), Lot Number: 23JME498; 249) DYNJ81280A, UDI-DI: 10195327491284(each), 40195327491285(case), Lot Number: 25LME467; 250) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24CBF775; 251) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24CBI987; 252) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24DBR594; 253) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24HBK264; 254) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 24IBD271; 255) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 24IBP146; 256) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 25CBA913; 257) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 25DBO402; 258) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 25EBG049; 259) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 25FBL492; 260) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 25HBI876; 261) DYNJ85078A, UDI-DI: 10195327532543(each), 40195327532544(case), Lot Number: 24HMA736; 262) DYNJ85340, UDI-DI: 10195327491239(each), 40195327491230(case), Lot Number: 23KMC008; 263) DYNJ86194A, UDI-DI: 10195327682293(each), 40195327682294(case), Lot Number: 24DBN706; 264) DYNJ86194A, UDI-DI: 10195327682293(each), 40195327682294(case), Lot Number: 24GBQ754; 265) DYNJ86194A, UDI-DI: 10195327682293(each), 40195327682294(case), Lot Number: 24GBQ919; 266) DYNJ86194A, UDI-DI: 10195327682293(each), 40195327682294(case), Lot Number: 24IBC003; 267) DYNJ86194A, UDI-DI: 10195327682293(each), 40195327682294(case), Lot Number: 24IBR498; 268) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 24CBG395; 269) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 24HBV552; 270) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 24IBL260; 271) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 25CBG746; 272) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 25LMD475; 273) DYNJ87378, UDI-DI: 10198459034787(each), 40198459034788(case), Lot Number: 24GMG790; 274) DYNJ87378, UDI-DI: 10198459034787(each), 40198459034788(case), Lot Number: 24HMA738; 275) DYNJ87378A, UDI-DI: 10198459186394(each), 40198459186395(case), Lot Number: 24KMI285; 276) DYNJ87378A, UDI-DI: 10198459186394(each), 40198459186395(case), Lot Number: 25EMB836; 277) DYNJ87378C, UDI-DI: 10198459390647(each), 40198459390648(case), Lot Number: 25GME299; 278) DYNJ87378D, UDI-DI: 10198459467257(each), 40198459467258(case), Lot Number: 25GMJ757; 279) DYNJ87378D, UDI-DI: 10198459467257(each), 40198459467258(case), Lot Number: 25IMA065; 280) DYNJ87378D, UDI-DI: 10198459467257(each), 40198459467258(case), Lot Number: 25IMC112; 281) DYNJ87378D, UDI-DI: 10198459467257(each), 40198459467258(case), Lot Number: 25JMI380; 282) DYNJ87451, UDI-DI: 10198459040283(each), 40198459040284(case), Lot Number: 24HBH452; 283) DYNJ88498, UDI-DI: 10198459166181(each), 40198459166182(case), Lot Number: 24KMC641; 284) DYNJ88498, UDI-DI: 10198459166181(each), 40198459166182(case), Lot Number: 24KMF610; 285) DYNJ901306D, UDI-DI: 10889942564736(each), 40889942564737(case), Lot Number: 23IMB807; 286) DYNJ902993F, UDI-DI: 10193489490817(each), 40193489490818(case), Lot Number: 23IMA480; 287) DYNJ902993F, UDI-DI: 10193489490817(each), 40193489490818(case), Lot Number: 23IMD509; 288) DYNJ905866, UDI-DI: 10193489547184(each), 40193489547185(case), Lot Number: 23CBW319; 289) DYNJ906292B, UDI-DI: 10193489877588(each), 40193489877589(case), Lot Number: 24BBV224; 290) DYNJ906292B, UDI-DI: 10193489877588(each), 40193489877589(case), Lot Number: 24CBI703; 291) DYNJ906841A, UDI-DI: 10193489392197(each), 40193489392198(case), Lot Number: 21GBG669; 292) DYNJ906841A, UDI-DI: 10193489392197(each), 40193489392198(case), Lot Number: 21GBR282; 293) DYNJ906841A, UDI-DI: 10193489392197(each), 40193489392198(case), Lot Number: 21HBN905; 294) DYNJ907739A, UDI-DI: 10193489976991(each), 40193489976992(case), Lot Number: 23GBW213; 295) DYNJ907739A, UDI-DI: 10193489976991(each), 40193489976992(case), Lot Number: 23IBK879; 296) DYNJ907739A, UDI-DI: 10193489976991(each), 40193489976992(case), Lot Number: 24CBA406; 297) DYNJ907739B, UDI-DI: 10195327671778(each), 40195327671779(case), Lot Number: 25ABE814; 298) DYNJ907739B, UDI-DI: 10195327671778(each), 40195327671779(case), Lot Number: 25ABP522; 299) DYNJ907739B, UDI-DI: 10195327671778(each), 40195327671779(case), Lot Number: 25CBE654; 300) DYNJ907739B, UDI-DI: 10195327671778(each), 40195327671779(case), Lot Number: 25JBR114; 301) DYNJ908953, UDI-DI: 10195327215293(each), 40195327215294(case), Lot Number: 23KME667; 302) DYNJ911062, UDI-DI: 10198459248139(each), 40198459248130(case), Lot Number: 25BBT142; 303) DYNJ911062, UDI-DI: 10198459248139(each), 40198459248130(case), Lot Number: 25FBI843; 304) DYNJ911062, UDI-DI: 10198459248139(each), 40198459248130(case), Lot Number: 25GBI875; 305) DYNJ911623, UDI-DI: 10198459441097(each), 40198459441098(case), Lot Number: 25HBH612; 306) DYNJT5739, UDI-DI: 10198459499661(each), 40198459499662(case), Lot Number: 25IMF120; 307) PHS393087007C, UDI-DI: 10193489222777(each), 40193489222778(case), Lot Number: 21ADA448
Where was it sold?
Worldwide - US Nationwide distribution.
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 98642This product is part of a recall event; the main page for the event is See RES for complete list recalled by Medline Industries.
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 Hearing Aids recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits: Discectomy Pack DYNJ86476B Ear recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled | Advanced Bionics | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Chp Cochlear Supplement Cds recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Zale Head & Neck Cds recalled | Medline Industries LP - Northfield | Foreign Material | Nationwide |