Teleflex HORIZON Titanium ligating clips recalled for missing cartridge safety feature
Teleflex LLC is recalling approximately 146,606 units of HORIZON Microclip Titanium Ligating Clips because a safety feature is missing from the clip cartridge. Without this step feature, clips may be positioned variably and applied inadequately to blood vessels during surgery.
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 recall with no reported illnesses or injuries. The hazard is potential inadequate application of surgical clips to blood vessels, which presents a risk of harm in surgical settings but no injury has been reported. Per the rubric, this meets the criterion for Score 3: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Teleflex LLC is voluntarily recalling the HORIZON Microclip Titanium Ligating Clips with tape (REF 005200), a surgical instrument used for vessel and tissue ligation in general surgical procedures. Affected units span 32 lot numbers and approximately 146,606 total units distributed worldwide.
The recall was initiated because the clip cartridges are missing a key step feature that restricts how the clip loads into the applier device. This step feature is designed to control the position of the clip in the applier jaw grooves. Without this feature, clips can be mounted in variable positions, potentially allowing them to load farther back in the grooves than intended. This variability may result in inappropriate or inadequate clip application to blood vessels and other vascular structures during surgery.
No illnesses or injuries have been reported in connection with this defect. The product is used only in surgical settings by trained medical professionals. Healthcare providers should verify lot numbers and contact Teleflex for additional information or replacement product.
The recalled product
- Product
- Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
- Manufacturer
- TELEFLEX LLC
- Hazard
- manufacturing-defect
- inadequate-application
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)
- UDI/DI 24026704696394
- Lot Numbers: 73A2200857
- 73A2300018
- 73A2300176
- 73A2300326
- 73A2300520
- 73A2300778
- 73D2200216
- 73D2200559
- 73E2200634
- 73E2200874
- 73E2201099
- 73F2200193
- 73F2200200
- 73F2200482
- 73F2200711
- 73G2200168
- 73G2200345
- 73G2200560
- 73G2200754
Distribution
Distribution scope not specified by the agency.
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