Endoplus 5mm Laparoscopic Grasper Recalled for Broken Jaw
Endoplus is recalling 81 units of 5mm Atraumatic Graspers because the moveable jaw broke during surgery. The devices were distributed in Florida, Texas, and Virginia.
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 failure (broken jaw) during surgery, which poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Endoplus, Inc. is recalling 81 units of 5mm Atraumatic Grasper S/A, Standard (REF 346VA). The non-sterile instruments are intended for grasping, dissecting, retraction, and clamping during laparoscopic surgery. The recall involves lot numbers D3, E3, and F3.
The recall was initiated due to multiple complaints reporting that the moveable jaw of the instrument broke during laparoscopic procedures. The affected units were distributed in the states of Florida, Texas, and Virginia.
Healthcare facilities and consumers should stop using these devices immediately. Endoplus, Inc. is the recalling firm responsible for the recall.
The recalled product
- Product
- ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the…
- Manufacturer
- Endoplus, Inc.
- Hazard
- Affected units
- 81
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 (4)
- Item: 346VA
- Lot Numbers: D3
- E3
- F3
Distribution
Part of a larger recall action
This product is one of 2 recalled by Endoplus, Inc. 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Endoplus, Inc.
See all →- HighEndoplus 5 mm Traumatic Grasper Recalled for Broken Jaw
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