Teleflex Horizon Manual-Load Ligating Clip Applier Recalled for Incorrect Etching
Teleflex Medical is recalling 49 units of Horizon Manual-Load Ligating Clip Appliers due to incorrect etching on the device.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 and involves a labeling/etching error (misbranding) without reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Teleflex Medical is recalling 49 units of the WECK Horizon Manual-Load Ligating Clip Applier, Curved Jaw, 11 inch (28cm), REF 337111. The recall was initiated because the devices have incorrect etching, which constitutes a misbranding issue.
The affected products were distributed worldwide, including in the United States (Florida, Illinois, Kentucky, Michigan, New York, and Oklahoma) and in Mexico and Canada. The specific lot number for the recalled units is 06F1515745.
Healthcare providers and facilities should stop using the affected devices and contact Teleflex Medical for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- WECK¿ Horizon" Manual-Load Ligating Clip Applier, For Medium-Large Size Horizon Ligation Clips Curved Jaw, 11 (28cm), Rx Only, REF 337111, Product Usage: Weck Closure Systems applier has been designed and calibrated for use with specific Horizon, Hemoclip Plus Hemoclip…
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 49
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 (2)
- Product Code: 337111
- Lot Number: 06F1515745.
Distribution
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