Recall archive / FDA device enforcement
Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, M... — FDA record Z-1394-2026
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
- 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; 9) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174; 10) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174A; 11) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174B; 12) KIT PEDS HEAD AND NECK, Model Number: DYKMBNDL196; 13) KIT OMF LEFORTE, Model Number: DYKMBNDL1A; 14) KIT OMF LEFORTE, Model Number: DYKMBNDL1B; 15) KIT OMF LEFORTE, Model Number: DYKMBNDL1C; 16) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32; 17) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32A; 18) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32B; 19) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66A; 20) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66B; 21) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88A; 22) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88B; 23) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88C; 24) KIT GEN SURG LAP VENTRA, Model Number: DYKMBNDL96C; 25) MINOR ENT PACK, Model Number: DYNJ01831I; 26) ENT BASIC PACK-LF, Model Number: DYNJ0387711F; 27) D AND C PACK-LF, Model Number: DYNJ0855090P; 28) CSS SINUS PACK, Model Number: DYNJ17005I; 29) CSS HEAD & NECK PACK, Model Number: DYNJ26780I; 30) NASALPLASTY #61-RF, Model Number: DYNJ27320V; 31) MASTOID PACK-WINTER PARK-LF, Model Number: DYNJ32060C; 32) T&A PACK, Model Number: DYNJ32809I; 33) HEAD AND NECK PACK, Model Number: DYNJ41169; 34) SIMPLE NECK DISSECTION, Model Number: DYNJ47481C; 35) ENT PACK, Model Number: DYNJ47882F; 36) ENT PACK, Model Number: DYNJ48401C; 37) ENT PACK, Model Number: DYNJ51934A; 38) PK,ORTHO-EXTREMITY-LOSROBLES, Model Number: DYNJ52916A; 39) HEAD & NECK PACK, Model Number: DYNJ54964A; 40) HEAD & NECK PACK, Model Number: DYNJ54964B; 41) ENT - MINOR ENT PACK-LF, Model Number: DYNJ56840B; 42) GLENNON HEAD AND NECK PACK-LF, Model Number: DYNJ57200C; 43) ENT PACK, Model Number: DYNJ57688F; 44) RF T AND A PACK, Model Number: DYNJ61393A; 45) T & A PACK, Model Number: DYNJ61935D; 46) ENT PACK, Model Number: DYNJ62093B; 47) ENT PACK, Model Number: DYNJ64024B; 48) OSCLJ HEAD AND NECK PACK, Model Number: DYNJ66509A; 49) HEAD AND NECK PACK, Model Number: DYNJ67208; 50) HEAD & NECK PACK, Model Number: DYNJ67328B; 51) PEDS HEAD AND NECK PACK, Model Number: DYNJ69746B; 52) NASAL PACK, Model Number: DYNJ81280A; 53) ENT-PLASTICS PACK, Model Number: DYNJ84258A; 54) ENT-PLASTICS PACK, Model Number: DYNJ84258B; 55) HEAD & NECK PACK, Model Number: DYNJ85078A; 56) ENT PACK, Model Number: DYNJ86194A; 57) EENT PACK, Model Number: DYNJ86235; 58) ENT PACK, Model Number: DYNJ87378; 59) ENT PACK,...
- 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
- 9051 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1394-2026
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: 21IBD399; 2) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21HBO921; 3) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22JBW315; 4) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22GBE731; 5) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22FBX804; 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: 25HLA345; 9) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25FLA904; 10) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25DLB145; 11) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25CLB002; 12) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24DLA606; 13) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24ALA266; 14) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21FBS478; 15) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21FBO537; 16) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21DBJ855; 17) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21CBD340; 18) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21BBG062; 19) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21ABK323; 20) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22GBH498; 21) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22FBT038; 22) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22EBS812; 23) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22DBL428; 24) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22CBX230; 25) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22BBA231; 26) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22ABG015; 27) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21JBB014; 28) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21JBA009; 29) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21IBP624; 30) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21HBF494; 31) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21GBE737; 32) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25GBX739; 33) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25EBH975; 34) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25DBQ008; 35) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25BBM402; 36) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25ABK769; 37) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24KBJ157; 38) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24HBU706; 39) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24GBR935; 40) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24GBD477; 41) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24EBF125; 42) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24DBV609; 43) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24ABL113; 44) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23JBT911; 45) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23JBQ487; 46) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23HBV381; 47) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23HBT877; 48) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23FBG212; 49) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23EBS366; 50) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23DBM060; 51) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23ABQ109; 52) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 22KBH786; 53) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 22IBU647; 54) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21FBQ554; 55) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21BBP836; 56) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21ABH824; 57) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 22EBO543; 58) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 22BBS429; 59) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 21LBY299; 60) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 25LBM606; 61) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24EBP260; 62) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24DBB691; 63) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24CBA389; 64) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 23JBN238; 65) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 23ABH675; 66) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 22LBI002; 67) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 22KBK464; 68) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBT411; 69) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBS041; 70) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBM511; 71) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBH559; 72) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBF521; 73) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21BBG851; 74) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21ABP337; 75) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 23BLA884; 76) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 22KLA452; 77) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 22JLB001; 78) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25FLA924; 79) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25FLA791; 80) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25DLA251; 81) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25CLA312; 82) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25BLA837; 83) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24JLA055; 84) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24ILA560; 85) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24HLB156; 86) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24HLA924; 87) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24GLA055; 88) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24FLA349; 89) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23LLA422; 90) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23KLA620; 91) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23JLA058; 92) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23ILA756; 93) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23HLA624; 94) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23DLA495; 95) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23CLA769; 96) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25ILA386; 97) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25ILA035; 98) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA843; 99) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA232; 100) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA179; 101) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21FBT798; 102) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21EBM706; 103) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21DBK216; 104) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21CBS031; 105) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21BBL111; 106) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21ABJ985; 107) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21ABJ862; 108) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22HBP925; 109) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22GBQ602; 110) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22GBF522; 111) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22FBE193; 112) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22EBQ053; 113) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22EBO633; 114) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 21JBJ743; 115) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 21IBD784; 116) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24GBP188; 117) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24GBC830; 118) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24EBU213; 119) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24DBU451; 120) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24CBR483; 121) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24ABK306; 122) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24ABH039; 123) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23LBP166; 124) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23IBA611; 125) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23HBX217; 126) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23HBH678; 127) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23FBP266; 128) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23EBT500; 129) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23EBB247; 130) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23DBP706; 131) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23BBS356; 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 distribution - US Nationwide.
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
- Feb 25, 2026
- Recall initiation date
- Jan 7, 2026
- Center classification date
- Feb 17, 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.