The Recall Desk
ModerateFDA (Devices)·Z-2723-2014·Announced 2014-10-08

Instrumed Reusable Laparoscopic Instruments Recalled for Updated Caution Statements

Instrumed International is recalling 156 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.

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 an FDA Class II recall involving the addition of caution statements to prevent potential tissue carbonation and ensure proper device usage, which fits the criteria for moderate severity involving labeling and usage safety updates.

Plain-English summary

Instrumed International, Inc. is recalling 156 reusable laparoscopic instruments. These instruments are packaged as non-sterile and are intended for use by qualified physicians in diagnostic and therapeutic laparoscopic and urologic procedures. The recall involves specific item numbers and lot numbers distributed nationwide in 40 states.

The recall is being conducted to add additional caution statements to the Instructions For Use for monopolar electrodes. The new statements specify that to avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp). Additionally, the statements clarify 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 were distributed 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 check their inventory for the specific item numbers and lot numbers listed in the recall notice and update their procedures to reflect the new voltage and useful life limitations.

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.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
156

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)

  • 1) Instrumed Item No.: 250-08680
  • Boss Instruments Catalog Code: 35-8015
  • Lot Number: 030411
  • 100110
  • 110210
  • 2) Instrumed Item No.: 250-08700
  • Boss Instruments Catalog Code: 35-8016
  • Lot Number: 030111
  • 3) Instrumed Item No.: 250-08700
  • Lot Number: 30111
  • 4) Instrumed Item No.: 250-08760
  • Boss Instruments Catalog Code: 35-8020
  • Lot Number: 020411
  • 070111
  • 100412
  • 110412
  • 5) Instrumed Item No.: 250-08770
  • Boss Instruments Catalog Code: 35-8020L
  • Lot Number: 020112
  • 110211

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 →

Related recalls

Same manufacturer · Instrumed International, Inc.

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Same hazard · tissue carbonation

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