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
- Affected units
- 2,588
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.
Part of a larger recall action
This product is one of 21 recalled by MEDLINE INDUSTRIES, LP - Northfield 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 21 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · dimensional variation
See all →- ModerateMedline Medical Procedure Kits Recalled for Dimensional Variation in Canister Fitting
FDA (Devices) · 2024-08-28
- ModerateMedline Medical Procedure Kits Recalled for Canister Fitting Issues
FDA (Devices) · 2024-08-28
- ModerateMedline Surgical Procedure Kits Recalled for Dimensional Fit Issue
FDA (Devices) · 2024-08-28
- HighMedline Med-Soft Liners Recalled for Potential Fitting Difficulty
FDA (Devices) · 2024-08-28
- ModerateMedline Medical Procedure Kits Recalled for Dimensional Variation
FDA (Devices) · 2024-08-28