Teleflex Gripper Graspers Recalled for Labeling Error
Teleflex Medical is recalling 160 Gripper Graspers due to a labeling error where they were mislabeled as Johans Graspers.
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 error, which aligns with the rubric for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Teleflex Medical is recalling 160 units of the Gripper Grasper, Reference ML003EE, Lot Number 73M1500175. The product is a sterile, prescription-only surgical instrument used to grasp, hold, and manipulate tissue during laparoscopic surgery.
The recall was initiated due to a labeling error. The Gripper Graspers were incorrectly labeled as Johans Graspers, while the Johans Graspers were incorrectly labeled as Gripper Graspers. This mislabeling could lead to the use of the wrong surgical instrument during a procedure.
The affected units were distributed in the United States to the states of Arizona, California, Florida, New York, North Carolina, and Texas. Healthcare facilities and consumers should stop using the affected products and contact Teleflex Medical for further instructions.
The recalled product
- Product
- Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human…
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 160
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 (1)
- Lot Number 73M1500175
Distribution
Part of a larger recall action
This product is one of 2 recalled by Teleflex Medical 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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