Applied Medical Recalls Epix and Direct Drive Laparoscopic Graspers
Applied Medical is recalling specific lots of Epix and Direct Drive Laparoscopic Graspers because the trigger may fracture, potentially leaving the jaws closed.
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 3/5 (High).
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: The recall involves a medical device with a potential for permanent patient injury, but the source explicitly states that the likelihood of this injury is 'highly unlikely' and no injuries have been reported, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Applied Medical Resources Corp is conducting a voluntary recall of 127,305 units of its Epix and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. These devices are used for grasping and manipulating tissue during general or laparoscopic surgery. The recall covers specific lot numbers distributed worldwide, including the United States and numerous international markets.
The recall is due to a potential defect where the ratchet trigger may fracture if a great enough force is applied. If this occurs, the jaws of the grasper may remain in the closed position. The source text notes that the likelihood of this situation occurring and resulting in permanent patient injury is highly unlikely.
Healthcare providers and consumers should check their inventory for the specific model numbers and lot numbers listed in the official recall notice. If a device is found to be affected, it should be removed from service and returned to Applied Medical Resources Corp according to their instructions.
The recalled product
- Product
- Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. Used for grasping and manipulating tissue during general or laparoscopic surgery.
- Manufacturer
- Applied Medical Resources Corp
- Affected units
- 127,305
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)
- 1145943
- 1145944
- 1145945
- 1145992
- 1145993
- 1145994
- 1146371
- 1147900
- 1147901
- 1147955
- 1148172
- 1148173
- 1148174
- 1148180
- 1148181
- 1148184
- 1148190
- 1148191
- 1148192
- 1148194
Distribution
Distributed nationwide across the United States.
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