Teleflex Johans Grasper Recall Due to Labeling Error
Teleflex Medical is recalling 160 Johans Graspers because they were mislabeled as Gripper Graspers. The sterile surgical instruments were distributed to six US states.
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. Per the rubric, minor labeling errors and voluntary precautionary recalls are assigned a score of 2 (Moderate).
Plain-English summary
Teleflex Medical is recalling 160 units of the Johans Grasper (Ref ML004EE), a sterile percutaneous surgical instrument. The product is indicated for penetrating soft tissue to access the human abdomen and is used to grasp, hold, and manipulate tissue during laparoscopic surgery.
The recall was initiated due to a labeling error. The Johans Graspers were incorrectly labeled as Gripper Graspers, while the Gripper Graspers were labeled as Johans Graspers. This mislabeling could lead to the use of the wrong instrument during surgical procedures.
The affected units are from Lot Number 73M1500176. The products were distributed in the United States to the states of Arizona, California, Florida, New York, North Carolina, and Texas. Healthcare facilities should stop using the affected devices and contact Teleflex Medical for further instructions.
The recalled product
- Product
- Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, 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 73M1500176
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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