The Recall Desk
ModerateFDA (Devices)·Z-2729-2014·Announced 2014-10-08

Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

Instrumed International is recalling 15 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: This is a Class II recall involving a documentation update (Instructions For Use) to clarify safety limits and product life, which aligns with the rubric for minor labeling or documentation issues.

Plain-English summary

Instrumed International, Inc. is recalling 15 reusable laparoscopic instruments. These instruments are intended to be used by qualified physicians to provide access, illumination, and visualization of internal structures during diagnostic and therapeutic laparoscopic or urologic procedures. The devices are packaged as non-sterile and require cleaning and sterilization prior to use.

The recall is initiated to add additional caution statements to the Instructions For Use for monopolar electrodes. The updated instructions 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 instructions 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 nationwide in the United States. Users should review the updated Instructions For Use and adhere to the specified voltage limits and usage cycles to ensure safe operation.

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
15

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 (16)

  • 1) Instrumed Item No.: 250-08930
  • Surgical Direct Catalog Code: SD175200.100
  • Lot Number: 070512
  • 2) Instrumed Item No.: 250-08700
  • Surgical Direct Catalog Code: SD11451.140
  • Lot Number: 080211
  • 3) Instrumed Item No.: 250-08930
  • Lot Numbers: 030112
  • 080212
  • 010113
  • 020113
  • 4) Instrumed Item No.: 250-08960
  • Surgical Direct Catalog Code: SD17520045.100
  • Lot Number: 070412
  • 5) Instrumed Item No.: 250-089360
  • Lot Number: 030413

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 · documentation issue

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