Aesculap Recalls DS Titanium Ligation Clip Appliers for Labeling Updates
Aesculap Implant Systems LLC is recalling 270 DS Titanium Ligation Clip Appliers to update instructions for use, adding contraindications for living donor nephrectomies.
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 updating labeling and instructions for use to prevent potential misuse, which aligns with the rubric for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Aesculap Implant Systems LLC is recalling 270 units of DS Titanium Ligation Clip Appliers, which are used in laparoscopic surgery. The recall covers specific product numbers including PL808R, PL802R, PL826R, PL817R, PL828R, PL809R, PL806R, PL818R, PL801R, PL816R, PL807R, PL822R, and PL827R. The devices were distributed in the US and Canada.
The recall was initiated to update the Instructions for Use (IFU). The company added a specific contraindication stating that the DS clips should not be used for living donor nephrectomies. Additionally, other contraindications were added, and the cleaning and sterilization instructions were updated.
Healthcare facilities and users who have these specific clip appliers should stop using them and contact Aesculap Implant Systems LLC for further instructions regarding the updated documentation.
The recalled product
- Product
- DS Titanium Ligation Clip Appliers, used in laparoscopic surgery
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
- Affected units
- 270
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Aesculap Implant Systems LLC 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.
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