Class IIOngoingZ-2108-2026

Medline Industries, LP recalls Medline Convenience Kits: 1) OB KIT

Medline Industries, LPNorthfield, IL, United StatesReported May 13, 2026 · 2 months ago

Legal News Analyst · May 13, 2026

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

UDI: 10198459565748(each), 40198459565749(case)
Lot #: 25KMF765; 2) DYKMBNDL165
UDI: 10193489477405(each), 40193489477406(case)
Lot #: 21ABI982; 3) DYKMBNDL165
UDI: 10193489477405(each), 40193489477406(case)
Lot #: 21ABT654; 4) DYKMBNDL165
UDI: 10193489477405(each), 40193489477406(case)
Lot #: 21DBA335; 5) DYKMBNDL165
UDI: 10193489477405(each), 40193489477406(case)
Lot #: 21EBE875; 6) DYKMBNDL165

What the firm is doing

An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-FGX1 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/14/26 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-

DistributionShow details

Worldwide - US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls

Class IIOngoingZ-2674-2026

Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…

Pneumatic Tourniquet
Under Investigation by firm

Zimmer Surgical IncOHJul 8, 2026

Class IIOngoingZ-2673-2026

Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…

Pneumatic Tourniquet
Under Investigation by firm

Zimmer Surgical IncOHJul 8, 2026

Class IIOngoingZ-2672-2026

W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…

Due to catheter separation

Aortic Aneurysm Treatment Endovascular Graft System
Under Investigation by firm

W L Gore & Associates,…AZJul 8, 2026