Merit Medical Systems Recalls Custom Angio Kits Due to Sterility Concerns
Merit Medical Systems is recalling 134 custom angio kits because a missing seal may compromise the sterility of the hand controller sheaths.
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: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a potential sterility breach, which is a significant risk but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause adverse health consequences).
Plain-English summary
Merit Medical Systems, Inc. is recalling 134 units of Custom Procedural Trays, specifically Merit's Custom Angio Kits (models K09T-09812B and K09T-09812C). The affected lot numbers are T252244, T318352, T342249, and T359185.
The recall was initiated because the seal between the white polyethylene and the clear plastic packaging may be missing. This defect results in a potential breach of the sterility of the Medrad Hand Controller Sheaths contained within the trays. These sheaths are intended to enable increased flow control for contrast delivery during medical procedures.
The affected products were distributed to a U.S. Military Hospital on base in Landstuhl, Germany. No specific instructions for consumers are provided in the source text, but the recall is limited to this specific distribution site.
The recalled product
- Product
- Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are h
- Manufacturer
- Merit Medical Systems, Inc.
- Category
- Medical Device — Surgical Trays
- Hazard
- Affected units
- 134
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 (5)
- Merit's Custom Angio kits K09T-09812B and K09T-09812C
- Lot numbers T252244
- T318352
- T342249
- T359185
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Merit Medical Systems, Inc.
See all →- HighSplashwire hydrophilic guide wire pouches have unsealed portions
FDA (Devices) · 2026-06-24
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- ModeratePhilips Bridge Prep Kit catheter may experience resistance during advancement
FDA (Devices) · 2026-05-06
- SevereDuraMax hemodialysis catheter sheath introducer may not split as intended
FDA (Devices) · 2026-04-01
Same hazard · sterility breach
See all →- ModerateMedline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
FDA (Devices) · 2026-07-22
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects
FDA (Devices) · 2026-07-22
- HighIntracept Access Instruments sterile barrier breach risk
FDA (Devices) · 2026-07-15
- ModerateSterile Tourniquet Hoses recalled for potential sterility breach
FDA (Devices) · 2026-07-08
- ModerateSterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
FDA (Devices) · 2026-07-08