Recall archive / FDA device enforcement
Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBND... — FDA record Z-1414-2026
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) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Number: DYNJ0456816O; 6) L & D PACK-LF, Model Number: DYNJ0456816P; 7) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ04692S; 8) VAGINAL DELIVERY PACK, Model Number: DYNJ16621B; 9) VAGINAL DELIVERY PACK, Model Number: DYNJ16621C; 10) DELIVERY PACK-LF, Model Number: DYNJ20546F; 11) VAGINAL DELIVERY PK, Model Number: DYNJ20979I; 12) VAGINAL DELIVERY PK, Model Number: DYNJ20979J; 13) VAGINAL DELIVERY PACK, Model Number: DYNJ24108D; 14) OB PACK-LF, Model Number: DYNJ26121I; 15) OB DELIVERY PACK, Model Number: DYNJ31024J; 16) OB DELIVERY PACK-LF, Model Number: DYNJ32139C; 17) DB VAG HYSTERECTOMY-LF, Model Number: DYNJ33590F; 18) MAJOR VAGINAL PACK, Model Number: DYNJ35488F; 19) ENS. ACCOUCHEMENT VAGINAL-LF, Model Number: DYNJ37331C; 20) VAG DELIVERY PACK, Model Number: DYNJ38481G; 21) VAG DELIVERY PACK, Model Number: DYNJ38481I; 22) VAG DELIVERY PACK, Model Number: DYNJ38481K; 23) OB PACK 2, Model Number: DYNJ39000D; 24) GYNECOLOGY VAGINAL KIT, Model Number: DYNJ40203A; 25) LABOR DELIVERY POUCH SCREEN, Model Number: DYNJ40918A; 26) L & D PACK WITHOUT INSTRUMENTS, Model Number: DYNJ44720B; 27) VAGINAL DELIVERY PACK, Model Number: DYNJ51377G; 28) FH VAG DELIVERY PK-LF, Model Number: DYNJ51794B; 29) VAGINAL DELIVERY PACK, Model Number: DYNJ55363A; 30) VAGINAL DELIVERY PACK, Model Number: DYNJ55363B; 31) MINOR VAGINAL PACK, Model Number: DYNJ61269B; 32) OB VAG DELIVERY PACK, Model Number: DYNJ61574; 33) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ61650; 34) OB-VAG PACK 9128190, Model Number: DYNJ62341; 35) HP VAGINAL DELIVERY PACK-LF, Model Number: DYNJ62402A; 36) L & D PACK, Model Number: DYNJ63216A; 37) L&D PACK, Model Number: DYNJ63757A; 38) GYN PACK DYNJ55833A, Model Number: DYNJ65145; 39) MINOR VAG PACK, Model Number: DYNJ68663; 40) UTHET TYLER OB PACK, Model Number: DYNJ68673A; 41) GYN VAGINAL PACK, Model Number: DYNJ68681; 42) VAGINAL DELIVERY PACK, Model Number: DYNJ69544A; 43) VAGINAL PACK, Model Number: DYNJ69774A; 44) LABOR & DELIVERY PACK-LF, Model Number: DYNJ84393; 45) DELIVERY PACK, Model Number: DYNJ87469A; 46) VAGINAL DELIVERY, Model Number: DYNJ901387A; 47) FLOYD DELIVERY, Model Number: DYNJ906937D; 48) OB VAGINAL MEDSTAR PACK-LF, Model Number: DYNJT3445; 49) OB PACK, Model Number: DYNJT5186; 50) VAGINAL DELIVERY KIT, Model Number: MNS13550A; 51) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 52) LABOR AND DELIVERY KIT, Model Number: MNS8950A
- 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
- 27320 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1414-2026
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) DYKM2326, UDI-DI: 10198459565748(each), 40198459565749(case), Lot Number: 25KMF765; 2) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 24ABK386; 3) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBV905; 4) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBA329; 5) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23HBR548; 6) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23EBP170; 7) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23BBT994; 8) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22LBB693; 9) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22KBS631; 10) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22IBB499; 11) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21LBX453; 12) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21KBM483; 13) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21JBQ910; 14) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBO498; 15) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBE978; 16) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21GBN267; 17) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21FBP760; 18) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21EBE875; 19) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21DBA335; 20) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABT654; 21) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABI982; 22) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 21ABC201; 23) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 21ABM087; 24) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JME434; 25) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JMC541; 26) DYNJ0456816P, UDI-DI: 10195327570545(each), 40195327570546(case), Lot Number: 24HMK119; 27) DYNJ04692S, UDI-DI: 10193489338454(each), 40193489338455(case), Lot Number: 21ADB239; 28) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25DMH878; 29) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25CME932; 30) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25AME014; 31) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24JMB353; 32) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24IMF157; 33) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24GMJ484; 34) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24FMF250; 35) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24DMI443; 36) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24CMB999; 37) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24BMA554; 38) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 23KMJ818; 39) DYNJ16621C, UDI-DI: 10198459421297(each), 40198459421298(case), Lot Number: 25GMD428; 40) DYNJ20546F, UDI-DI: 10193489346084(each), 40193489346085(case), Lot Number: 22IMG976; 41) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22FMB686; 42) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22EMF465; 43) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22DMB332; 44) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22CME094; 45) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22AMA608; 46) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21KMB071; 47) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21JMA483; 48) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21IMD851; 49) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21HMD738; 50) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21GMB531; 51) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21DMD921; 52) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21CME149; 53) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 23AMJ134; 54) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22LMA315; 55) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22IMH408; 56) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22GMH899; 57) DYNJ24108D, UDI-DI: 10195327425258(each), 40195327425259(case), Lot Number: 23IBS023; 58) DYNJ24108D, UDI-DI: 10195327425258(each), 40195327425259(case), Lot Number: 23IBA365; 59) DYNJ24108D, UDI-DI: 10195327425258(each), 40195327425259(case), Lot Number: 23GBU622; 60) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25IBJ589; 61) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25HBM068; 62) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25GBJ925; 63) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25FBE718; 64) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25EBA350; 65) DYNJ31024J, UDI-DI: 10195327139544(each), 40195327139545(case), Lot Number: 22IMF645; 66) DYNJ32139C, UDI-DI: 10193489588576(each), 40193489588577(case), Lot Number: 25DBK245; 67) DYNJ33590F, UDI-DI: 10193489220759(each), 40193489220750(case), Lot Number: 20LDC125; 68) DYNJ35488F, UDI-DI: 10193489803488(each), 40193489803489(case), Lot Number: 23JMB591; 69) DYNJ37331C, UDI-DI: 10889942670512(each), 40889942670513(case), Lot Number: 25GBN237; 70) DYNJ38481G, UDI-DI: 10193489727937(each), 40193489727938(case), Lot Number: 20LMD360; 71) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21LMB210; 72) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21JME107; 73) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21JMC579; 74) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21IMB736; 75) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21GMB665; 76) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21DMB477; 77) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23IMD484; 78) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23HMC301; 79) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23GMD513; 80) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23EMD649; 81) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23CMF409; 82) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMJ499; 83) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMC555; 84) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMC551; 85) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMC268; 86) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22IMG983; 87) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22GMH656; 88) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22EME995; 89) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22CMB285; 90) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22CMA009; 91) DYNJ39000D, UDI-DI: 10195327319656(each), 40195327319657(case), Lot Number: 23JMB120; 92) DYNJ40203A, UDI-DI: 10193489670998(each), 40193489670999(case), Lot Number: 21GDA744; 93) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23GBM044; 94) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23FBM020; 95) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23EBQ232; 96) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23ABO451; 97) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 22HBL591; 98) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 22FBP490; 99) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 22EBD699; 100) DYNJ44720B, UDI-DI: 10195327277512(each), 40195327277513(case), Lot Number: 23FDB511; 101) DYNJ51377G, UDI-DI: 10193489906325(each), 40193489906326(case), Lot Number: 23HBO866; 102) DYNJ51794B, UDI-DI: 10193489644708(each), 40193489644709(case), Lot Number: 21ADA465; 103) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22OBB980; 104) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22EBI837; 105) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22CBW142; 106) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22CBW139; 107) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21LBT403; 108) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21JBY447; 109) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21BBB866; 110) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21ABH443; 111) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23HBT039; 112) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23GBN972; 113) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23FBE833; 114) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23EBJ019; 115) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23CBA634; 116) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23ABO534; 117) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22JBD960; 118) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22IBQ631; 119) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22HBM755; 120) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22HBM753; 121) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22HBA092; 122) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22FBO672; 123) DYNJ61269B, UDI-DI: 10195327054687(each), 40195327054688(case), Lot Number: 22OBD693; 124) DYNJ61574, UDI-DI: 10193489601084(each), 40193489601085(case), Lot Number: 23BMF067; 125) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 23FBR019; 126) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 23DBL820; 127) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 22JBW013; 128) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 22HBT023; 129) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21VBA541; 130) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21LBT378; 131) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21LBT375; 132) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21KBV669; 133) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number... |
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.