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-2108-2026
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) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38B; 6) L & D PACK-LF, Model Number: DYNJ0456816O; 7) L & D PACK-LF, Model Number: DYNJ0456816P; 8) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ04692S; 9) VAGINAL DELIVERY PACK, Model Number: DYNJ16621B; 10) VAGINAL DELIVERY PACK, Model Number: DYNJ16621C; 11) DELIVERY PACK-LF, Model Number: DYNJ20546F; 12) VAGINAL DELIVERY PK, Model Number: DYNJ20979I; 13) VAGINAL DELIVERY PK, Model Number: DYNJ20979J; 14) VAGINAL DELIVERY PACK, Model Number: DYNJ24108D; 15) OB PACK-LF, Model Number: DYNJ26121I; 16) OB DELIVERY PACK, Model Number: DYNJ31024J; 17) OB DELIVERY PACK-LF, Model Number: DYNJ32139C; 18) DB VAG HYSTERECTOMY-LF, Model Number: DYNJ33590F; 19) MAJOR VAGINAL PACK, Model Number: DYNJ35488F; 20) ENS. ACCOUCHEMENT VAGINAL-LF, Model Number: DYNJ37331C; 21) VAG DELIVERY PACK, Model Number: DYNJ38481G; 22) VAG DELIVERY PACK, Model Number: DYNJ38481I; 23) VAG DELIVERY PACK, Model Number: DYNJ38481K; 24) OB PACK 2, Model Number: DYNJ39000D; 25) GYNECOLOGY VAGINAL KIT, Model Number: DYNJ40203A; 26) LABOR DELIVERY POUCH SCREEN, Model Number: DYNJ40918A; 27) L & D PACK WITHOUT INSTRUMENTS, Model Number: DYNJ44720B; 28) VAGINAL DELIVERY PACK, Model Number: DYNJ51377G; 29) FH VAG DELIVERY PK-LF, Model Number: DYNJ51794B; 30) VAGINAL DELIVERY PACK, Model Number: DYNJ55363A; 31) VAGINAL DELIVERY PACK, Model Number: DYNJ55363B; 32) DELIVERY PACK, Model Number: DYNJ55373A; 33) VAGINAL DELIVERY PACK, Model Number: DYNJ59403F; 34) MINOR VAGINAL PACK, Model Number: DYNJ61269B; 35) OB VAG DELIVERY PACK, Model Number: DYNJ61574; 36) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ61650; 37) OB-VAG PACK 9128190, Model Number: DYNJ62341; 38) HP VAGINAL DELIVERY PACK-LF, Model Number: DYNJ62402A; 39) LABOR AND DELIVERY TRAY, Model Number: DYNJ62722B; 40) L & D PACK, Model Number: DYNJ63216A; 41) L&D PACK, Model Number: DYNJ63757A; 42) GYN PACK DYNJ55833A, Model Number: DYNJ65145; 43) MINOR VAG PACK, Model Number: DYNJ68663; 44) UTHET TYLER OB PACK, Model Number: DYNJ68673A; 45) GYN VAGINAL PACK, Model Number: DYNJ68681; 46) VAGINAL DELIVERY PACK, Model Number: DYNJ69544A; 47) VAGINAL PACK, Model Number: DYNJ69774A; 48) LABOR & DELIVERY PACK-LF, Model Number: DYNJ84393; 49) DELIVERY PACK, Model Number: DYNJ87469A; 50) DELIVERY B, Model Number: DYNJ900351T; 51) VAGINAL DELIVERY, Model Number: DYNJ901387A; 52) FLOYD DELIVERY, Model Number: DYNJ906937D; 53) OB VAGINAL MEDSTAR PACK-LF, Model Number: DYNJT3445; 54) OB PACK, Model Number: DYNJT5186; 55) VAGINAL DELIVERY KIT, Model Number: MNS13550A; 56) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 57) 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
- 29192
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2108-2026
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: 21ABI982; 3) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABT654; 4) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21DBA335; 5) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21EBE875; 6) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21FBP760; 7) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21GBN267; 8) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBE978; 9) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBO498; 10) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21JBQ910; 11) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21KBM483; 12) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21LBX453; 13) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22IBB499; 14) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22KBS631; 15) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22LBB693; 16) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23BBT994; 17) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23EBP170; 18) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23HBR548; 19) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBA329; 20) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBV905; 21) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 24ABK386; 22) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 21ABC201; 23) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 23JLA066; 24) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 23JLA538; 25) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 21ABM087; 26) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 23IBT256; 27) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 23JBB705; 28) DYKMBNDL38B, UDI-DI: 10195327660017(each), 40195327660018(case), Lot Number: 24IBK537; 29) DYKMBNDL38B, UDI-DI: 10195327660017(each), 40195327660018(case), Lot Number: 24IBM370; 30) DYKMBNDL38B, UDI-DI: 10195327660017(each), 40195327660018(case), Lot Number: 24IBW265; 31) DYKMBNDL38B, UDI-DI: 10195327660017(each), 40195327660018(case), Lot Number: 24JBK520; 32) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JMC541; 33) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JME434; 34) DYNJ0456816P, UDI-DI: 10195327570545(each), 40195327570546(case), Lot Number: 24HMK119; 35) DYNJ04692S, UDI-DI: 10193489338454(each), 40193489338455(case), Lot Number: 21ADB239; 36) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 23KMJ818; 37) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24BMA554; 38) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24CMB999; 39) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24DMI443; 40) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24FMF250; 41) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24GMJ484; 42) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24IMF157; 43) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24JMB353; 44) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25AME014; 45) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25CME932; 46) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25DMH878; 47) DYNJ16621C, UDI-DI: 10198459421297(each), 40198459421298(case), Lot Number: 25GMD428; 48) DYNJ16621C, UDI-DI: 10198459421297(each), 40198459421298(case), Lot Number: 25HMC583; 49) DYNJ20546F, UDI-DI: 10193489346084(each), 40193489346085(case), Lot Number: 22IMG976; 50) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21CME149; 51) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21DMD921; 52) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21GMB531; 53) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21HMD738; 54) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21IMD851; 55) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21JMA483; 56) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21KMB071; 57) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22AMA608; 58) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22CME094; 59) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22DMB332; 60) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22EMF465; 61) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22FMB686; 62) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22GMH899; 63) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22IMH408; 64) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22LMA315; 65) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 23AMJ134; 66) DYNJ24108D, UDI-DI: 10195327425258(each), 40195327425259(case), Lot Number: 23GBU622; 67) DYNJ24108D, UDI-DI: 10195327425258(each), 40195327425259(case), Lot Number: 23IBA365; 68) DYNJ24108D, UDI-DI: 10195327425258(each), 40195327425259(case), Lot Number: 23IBS023; 69) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25EBA350; 70) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25FBE718; 71) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25GBJ925; 72) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25HBM068; 73) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25IBJ589; 74) DYNJ31024J, UDI-DI: 10195327139544(each), 40195327139545(case), Lot Number: 22IMF645; 75) DYNJ32139C, UDI-DI: 10193489588576(each), 40193489588577(case), Lot Number: 25DBK245; 76) DYNJ33590F, UDI-DI: 10193489220759(each), 40193489220750(case), Lot Number: 20LDC125; 77) DYNJ35488F, UDI-DI: 10193489803488(each), 40193489803489(case), Lot Number: 23JMB591; 78) DYNJ37331C, UDI-DI: 10889942670512(each), 40889942670513(case), Lot Number: 25GBN237; 79) DYNJ38481G, UDI-DI: 10193489727937(each), 40193489727938(case), Lot Number: 20LMD360; 80) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21DMB477; 81) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21GMB665; 82) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21IMB736; 83) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21JMC579; 84) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21JME107; 85) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21LMB210; 86) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22CMA009; 87) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22CMB285; 88) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22EME995; 89) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22GMH656; 90) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22IMG983; 91) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMC268; 92) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMC551; 93) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMC555; 94) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMJ499; 95) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23CMF409; 96) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23EMD649; 97) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23GMD513; 98) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23HMC301; 99) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23IMD484; 100) DYNJ39000D, UDI-DI: 10195327319656(each), 40195327319657(case), Lot Number: 23JMB120; 101) DYNJ40203A, UDI-DI: 10193489670998(each), 40193489670999(case), Lot Number: 21GDA744; 102) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 22EBD699; 103) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 22FBP490; 104) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 22HBL591; 105) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23ABO451; 106) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23EBQ232; 107) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23FBM020; 108) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23GBM044; 109) DYNJ44720B, UDI-DI: 10195327277512(each), 40195327277513(case), Lot Number: 23FDB511; 110) DYNJ51377G, UDI-DI: 10193489906325(each), 40193489906326(case), Lot Number: 23HBO866; 111) DYNJ51794B, UDI-DI: 10193489644708(each), 40193489644709(case), Lot Number: 21ADA465; 112) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21ABH443; 113) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21BBB866; 114) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21JBY447; 115) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21LBT403; 116) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22CBW139; 117) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22CBW142; 118) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22EBI837; 119) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22OBB980; 120) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22FBO672; 121) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22HBA092; 122) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22HBM753; 123) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22HBM755; 124) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22IBQ631; 125) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22JBD960; 126) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23ABO534; 127) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23CBA634; 128) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23EBJ019; 129) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23FBE833; 130) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23GBN972; 131) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23HBT039; 132) DYNJ55373A, UDI-DI: 10889942690947(each), 40889942690948(case), Lot Number: 23FBV941; 133) DYNJ59403F, UDI-DI: 10195327441999(each), 40195327441990(cas... |
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.