Medline procedure kit has dimensional variation affecting canister fitting
Medline is recalling 3400 units of ENDO medical procedure kits due to a dimensional variation that may cause difficulty fitting the kit into its outer canister.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a dimensional defect that could impair device assembly. With no reported injuries or illnesses, this qualifies as a risk-of-harm product where injury has not yet been reported, per the severity rubric.
Plain-English summary
Medline Industries is recalling approximately 3,400 units of its ENDO medical procedure kits (Reference DYKE1410A) worldwide.
The kits have a slight dimensional variation that has the potential to cause increased difficulty when fitting the kit into its outer canister. This dimensional problem could affect the proper setup and use of the procedure kit.
The recalled kits have been distributed throughout the United States and internationally to Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. The recall involves multiple lot numbers manufactured between 2022 and 2023.
The recalled product
- Product
- Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410A
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure kit
- Hazard
- fitting-difficulty
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 (14)
- a) REF DYKE1410A
- UDI/DI 40193489269223 (case)
- 10193489269222 (unit)
- Lot Numbers: 22EBO806
- 22GBW168
- 22IBP461
- 22LBC090
- 22LBM513
- 23BBP271
- 23DBM055
- 23EBQ913
- 23GBI842
- 23IBF978
- 23KBK768
Distribution
Distributed nationwide across the United States.
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