The Recall Desk
ModerateFDA (Devices)·Z-2730-2014·Announced 2014-10-08

Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Warnings

Instrumed International is recalling reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful 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 indicates the action is to add caution statements to existing instructions rather than addressing a reported defect or injury, fitting the criteria for a moderate, precautionary labeling update.

Plain-English summary

Instrumed International, Inc. is recalling reusable laparoscopic instruments that are packaged as non-sterile. These instruments are intended for qualified physicians to provide access, illumination, and visualization of internal structures during diagnostic and therapeutic laparoscopic or urologic procedures. The recall involves two specific instruments identified by Instrumed Item No. 250-08660 and Surgimed MLB Catalog Code 91-112, with lot numbers 040110 and 100112.

The recall is being conducted to add additional caution statements to the Instructions For Use for monopolar electrodes. The new warnings specify that to avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. Additionally, the updated instructions state 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 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. Healthcare facilities and users should verify their inventory against the provided item and lot numbers and follow the updated safety instructions.

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
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 (4)

  • 1) Instrumed Item No.: 250-08660
  • Surgimed - MLB Catalog Code: 91-112
  • Lot Numbers: 040110
  • 100112

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

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Same hazard · mis labeling

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