Recall archive / FDA device enforcement
See RES for full list. Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COC... — FDA record Z-2097-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 7, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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;
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 11575 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2097-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 13, 2026
- Recall initiation date
- Jan 7, 2026
- Center classification date
- May 7, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.