Medline Labor and Delivery Convenience Kits Recalled Over Sterilization Calibration
Medline is recalling 27,320 labor and delivery convenience kits due to calibration issues with sterilization equipment that may affect the sterility assurance level of the devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall. Per the rubric, FDA Class II recalls with potential to compromise sterility assurance of medical devices used in labor and delivery are classified as Severe (score 4), as they present a risk of serious health consequences if non-sterile devices are used in invasive procedures.
Plain-English summary
Medline Industries, LP is recalling 27,320 units of its labor and delivery convenience kits, including models such as OB KIT, LABOR DELIVERY TUBAL LIGAT, and various L&D and VAGINAL DELIVERY PACKS. The recall covers numerous model numbers and lot numbers, with worldwide distribution including US nationwide.
The recall is being issued because Medline identified calibration issues related to the equipment used to sterilize and package the devices. While all products were exposed to the validated sterilization and packaging cycles, the calibration issues have the potential to impact the sterility assurance level (SAL) of the recalled products.
Healthcare facilities and providers that received the affected kits should follow their organization's recall procedures and contact Medline Industries, LP for replacement or credit. Consumers or patients with questions about the recall should contact their healthcare provider.
The recall was classified by the FDA as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- 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…
- Manufacturer
- Medline Industries, LP
- Affected units
- 27,320
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1) DYKM2326
- UDI-DI: 10198459565748(each)
- 40198459565749(case)
- Lot Number: 25KMF765
- 2) DYKMBNDL165
- UDI-DI: 10193489477405(each)
- 40193489477406(case)
- Lot Number: 24ABK386
- 3) DYKMBNDL165
- Lot Number: 23KBV905
- 4) DYKMBNDL165
- Lot Number: 23KBA329
- 5) DYKMBNDL165
- Lot Number: 23HBR548
- 6) DYKMBNDL165
- Lot Number: 23EBP170
- 7) DYKMBNDL165
- Lot Number: 23BBT994
- 8) DYKMBNDL165
- Lot Number: 22LBB693
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 42 products in this recall →Related recalls
Same manufacturer · Medline Industries, LP
See all →- ModerateMedline surgical convenience kits recalled for non-conforming cannula components
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- ModerateMedline Foot Ankle Convenience Kit Recalled for Shelf-Life Discrepancy
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alerts
FDA (Devices) · 2026-10-21
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- SevereMedline Labor and Delivery Kits Recalled for Sterilization Calibration Issues
FDA (Devices) · 2026-05-13
- ModerateMedline Convenience Kits recalled due to sterilization calibration issues
FDA (Devices) · 2026-05-13
- ModerateMedline Surgical Convenience Kits Recalled Due to Sterilization Calibration Issues
FDA (Devices) · 2026-05-13
- ModerateMedline Convenience Kits Recalled for Potential Sterilization Calibration Issues
FDA (Devices) · 2026-05-13
- HighMedline Surgical Convenience Kits Recalled for Sterilization Calibration Issues
FDA (Devices) · 2026-05-13
- ModerateMedline Convenience Kits sterilization calibration issue recalled
FDA (Devices) · 2026-05-13