Medline ENDO KIT procedure kits recalled for dimensional variation affecting fit
Medline is recalling 2,588 ENDO KIT medical procedure kits worldwide due to dimensional variation that may cause difficulty fitting into the 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: FDA Class II medical device recall affecting a procedure kit with a dimensional variation that could impact proper assembly and use. While no injuries have been reported, the device is a risk-of-harm product where proper fit and function are critical to safe clinical use.
Plain-English summary
Medline Industries is recalling 2,588 ENDO KIT medical procedure kits (Reference DYK1012268E1) due to a dimensional variation affecting fit. The variation may result in increased difficulty fitting the kits into their outer canister during preparation or assembly.
The recalled kits were distributed worldwide, including throughout the United States and to Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. Affected lot numbers are 22FBU931, 22HBL619, 22JBG192, 22LBH957, 23CBU467, 23FBS319, 23IBT789, and 23KMH977.
The dimensional variation poses a potential risk if not properly managed during kit preparation. Healthcare facilities should verify their stock against the lot numbers and contact Medline with any questions regarding the recall.
The recalled product
- Product
- Medline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kit
- Hazard
- dimensional-variation
- fitting-defect
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 (11)
- a) REF DYK1012268E1
- UDI/DI 40884389919089 (case)
- 10884389919088 (unit)
- Lot Numbers: 22FBU931
- 22HBL619
- 22JBG192
- 22LBH957
- 23CBU467
- 23FBS319
- 23IBT789
- 23KMH977
Distribution
Distributed nationwide across the United States.
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