The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2722-2014·Announced 2014-10-08

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.

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, 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…
Manufacturer
Instrumed International, Inc.
Category
Medical Device — Surgical Instruments
Hazard
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

Distributed nationwide across the United States.

The notice also names 45 states specifically:

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 →

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