The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2721-2014·Announced 2014-10-08

Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

Instrumed International is recalling 65 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.

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 and involves updating documentation (Instructions For Use) to include safety cautions regarding voltage and useful life, which aligns with the rubric for moderate severity involving labeling or documentation issues without reported injuries.

Plain-English summary

Instrumed International, Inc. is recalling 65 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 for diagnostic and therapeutic laparoscopic and urologic procedures.

The updated IFU includes two specific caution statements: first, to avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes; second, 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.

Healthcare facilities and users should stop using the affected instruments and contact Instrumed International for further instructions regarding the updated documentation. The recall involves specific lot numbers and catalog codes identified in the agency's structured data.

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
65

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.: 250-08800
  • Adler Instrument Company Catalog Code: 70-0300
  • Lot Number: 070113
  • 2) Instrumed Item No.: 250-08860
  • Adler Instrument Company Catalog Code: 70-0319
  • Lot Number: 030312
  • 070411
  • 3) Instrumed Item No.: 250-08930
  • Adler Instrument Company Catalog Code: 70-0318
  • Lot Number: 010113
  • 020113
  • 030112
  • 050412
  • 060413
  • 070512
  • 090213
  • 100113
  • 100411
  • 4) Instrumed Item No.: 250-08960
  • Adler Instrument Company Catalog Code: AD98-1008

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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