Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions
Instrumed International is recalling 83 reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.
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, but the source text indicates the action is to add caution statements to the instructions for use rather than addressing a reported injury or defect, fitting the criteria for a moderate, precautionary labeling update.
Plain-English summary
Instrumed International, Inc. is recalling 83 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 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) 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, 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. The specific product is identified by Instrumed Item No. 250-08930, Pilling Weck Inc. / Teleflex Medical Catalog Code 728163, and Lot Number 66745. Users should stop using the affected instruments and contact the recalling firm for 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…
- Manufacturer
- Instrumed International, Inc.
- Hazard
- Affected units
- 83
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
- Pilling Weck Inc. / Teleflex Medical Catalog Code: 728163
- Lot Number: 66745
Distribution
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.
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