Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions
Instrumed International is recalling reusable laparoscopic instruments to add caution statements regarding voltage limits and product life.
What this means for you
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, but the source text describes a documentation update (adding caution statements) without reporting any illnesses, injuries, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Instrumed International, Inc. is recalling two reusable laparoscopic instruments. The recall is initiated to add additional caution statements to the Instructions For Use for monopolar electrodes. These updates specify that the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) to avoid tissue carbonation, and that the useful life of the product is less than or equal to 50 cycles and less than or equal to 2 years.
The affected instruments are packaged as non-sterile and are intended for use by qualified physicians in diagnostic and therapeutic laparoscopic or urologic procedures. The specific items involved are identified by Instrumed Item No. 250-08930, Ambler Surgical Corporation Catalog Code J647-6, and Lot Number 060412.
The products were distributed nationwide in the United States, including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. Users should review the updated Instructions For Use to ensure compliance with the new voltage and usage limits.
The recalled product
- Product
- Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
- Manufacturer
- Instrumed International, Inc.
- Affected units
- 2
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 (3)
- 1) Instrumed Item No.: 250-08930
- Ambler Surgical Corporation Catalog Code: J647-6
- Lot Number: 060412
Distribution
Part of a larger recall action
This product is one of 10 recalled by Instrumed International, 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 10 products in this recall →Related recalls
Same manufacturer · Instrumed International, Inc.
See all →- LowInstrumed Withdraws McKenzie Perforator Drills for Regulatory Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Withdraws McKenzie Enlarging Burrs Due to Regulatory Non-Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Recalls Cloward Spanner Gauges Due to Regulatory Non-Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Recalls Traction Tong Replacement Screws for Regulatory Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Recalls Schoitz Weights for Regulatory Compliance Issues
FDA (Devices) · 2014-12-17
Same hazard · documentation update
See all →- LowPhilips S4-1 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips Mini Multi TEE transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips OMNI III TEE transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips X7-2 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01
- LowPhilips 3D6-2 ultrasound transducer labelling updated to define useful life
FDA (Devices) · 2026-04-01