Medline catheter procedure kits recalled for potential sterility compromise
Medline is recalling 8,830 medical procedure convenience kits with potential breather pouch seal failure that could allow non-sterile product use.
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 is an FDA Class II recall involving a potential sterility compromise of medical devices. No illnesses or injuries have been reported. The hazard is theoretical—the potential for non-sterile product use if seals fail—which per the severity rubric limits the score to 3 (High).
Plain-English summary
Medline Industries, LP is recalling 8,830 medical procedure convenience kits used for urinary catheterization procedures (Foley catheter trays). These kits are affected if they were packaged in breather pouches with lot number 323080002.
The recall is due to a potential vendor seal failure on the breather pouches. If the pouch seal becomes open or unsealed during storage or handling, the sterile condition of the contents may be compromised, creating the potential for non-sterile product use.
These kits were distributed worldwide, including throughout the United States, Canada, and Panama. No illnesses or injuries have been reported.
Healthcare facilities and users should verify the lot number on their kits. Those with lot 323080002 should contact Medline Industries for instructions on replacement or product verification before use.
The recalled product
- Product
- Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML, REF DYND150200S; b) TRAY FOL LATX UM COUD 16FR MF, REF DYND150216CS; c) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S; d) TRAY FOLEY LTX 16FR 10ML UM MF, REF DYND150216S;
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile
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)
- a) REF DYND150200S
- UDI/DI 40195327387885 (each)
- 10195327387884 (case)
- Lot Numbers: 23LBK182
- b) REF DYND150216CS
- UDI/DI 40195327388059 (each)
- 10195327388058 (case)
- Lot Numbers: 23LBK183
- c) REF DYND150216S
- UDI/DI 40195327387366 (each)
- 10195327387365 (case)
- Lot Numbers: 23LBO854
- d) REF DYND150216S
- Lot Numbers: 23LBL067
- e) REF DYND150218CS
- UDI/DI 40195327388066 (each)
- 10195327388065 (case)
- Lot Numbers: 23LBL068
- f) REF DYND150218S
- UDI/DI 40195327388004 (each)
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03