The Recall Desk
ModerateFDA (Devices)·Z-2726-2014·Announced 2014-10-08

Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

Instrumed International is recalling 122 reusable laparoscopic instruments to add caution statements regarding voltage limits and product 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 classified as FDA Class II, but the source text describes a documentation update (adding caution statements to the IFU) rather than a physical defect or reported injury, fitting the criteria for a moderate severity labeling/documentation issue.

Plain-English summary

Instrumed International, Inc. is recalling 122 reusable laparoscopic instruments. The recall is initiated to add additional caution statements to the Instructions For Use (IFU) for monopolar electrodes. The instruments are intended to be used by qualified physicians to provide access, illumination, and visualization of internal structures and for manipulating soft tissue in diagnostic and therapeutic laparoscopic and urologic procedures.

The specific safety updates added to the IFU state 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 IFU now specifies 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 identified by Instrumed Item No. 250-08930, Specialty Care Catalog Code 30-92221, and Lot Number 040413. The products were distributed nationwide in the United States to the following states: 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 should stop using the affected instruments and contact the manufacturer for instructions on how to obtain the updated Instructions For Use.

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
122

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
  • Specialty Care Catalog Code: 30-92221
  • Lot Number: 040413

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.

See all →

Same hazard · documentation update

See all →