Medline Convenience Kits recalled due to sterilization calibration issues
Medline Industries is recalling two models of gastrointestinal convenience kits (BAPTIST FLOYD ENDO GI KIT and GI LAB OTHER ENDO KIT) due to calibration issues in sterilization equipment that may have impacted the sterility assurance level of the products.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source text indicates calibration issues with sterilization equipment that have the potential to impact sterility assurance, but no illnesses, injuries, or actual confirmed loss of sterility has been reported. The recall is based on a potential risk rather than confirmed harm.
Plain-English summary
Medline Industries, LP is recalling Medline Convenience Kits, specifically the BAPTIST FLOYD ENDO GI KIT (Model DYKE1455B) and GI LAB OTHER ENDO KIT (Model DYKE1721), distributed nationwide in the United States. A total of 23,238 units have been identified as affected.
Medline has identified calibration issues with the equipment used to sterilize and package these devices. While all products were exposed to the validated sterilization and packaging cycles, the calibration issues identified have the potential to impact the sterility assurance level (SAL) of the recalled products.
Healthcare providers and facilities that have received these kits should stop using the affected lots and contact Medline Industries for guidance on next steps. Affected lot numbers for the BAPTIST FLOYD ENDO GI KIT include Lot Number 22IBV801. Affected lot numbers for the GI LAB OTHER ENDO KIT include lot numbers 21BBK795, 21CBH534, 21CBH946, 21IBL687, 21KBP287, 22EMH737, 22EMI534, 22FMD365, 22FMH954, 22GMH729, 22HMD809, 22JMC784, 22LMF786, 23BMC768, 23CMB706, 23CMC558, 23CMG332, 23EMF635, 23GMC067, 23GMF416, 23HMG566, 23IMF495, and 23KMC417.
The recalled product
- Product
- Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
- Manufacturer
- Medline Industries, LP
- Hazard
- sterilization-failure
- equipment-calibration
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) DYKE1455B
- UDI-DI: 10193489760781(each)
- 40193489760782(case)
- Lot Number: 22IBV801
- 2) DYKE1721
- UDI-DI: 10193489258684(each)
- 40193489258685(case)
- Lot Number: 21BBK795
- 3) DYKE1721
- Lot Number: 21CBH534
- 4) DYKE1721
- Lot Number: 21CBH946
- 5) DYKE1721
- Lot Number: 21IBL687
- 6) DYKE1721
- Lot Number: 21KBP287
- 7) DYKE1721
- Lot Number: 22EMH737
- 8) DYKE1721
- Lot Number: 22EMI534
Distribution
Distributed nationwide across the United States.
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