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.
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: 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…
- Manufacturer
- Instrumed International, Inc.
- 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
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 →- LowInstrumed Withdraws McKenzie Perforator Drills for Regulatory Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Withdraws McKenzie Enlarging Burrs Due to Regulatory Non-Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Recalls Cloward Spanner Gauges Due to Regulatory Non-Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Recalls Traction Tong Replacement Screws for Regulatory Compliance
FDA (Devices) · 2014-12-17
- LowInstrumed Recalls Schoitz Weights for Regulatory Compliance Issues
FDA (Devices) · 2014-12-17
Same hazard · documentation issue
See all →- LowHeartSine Defibrillators Recalled for Missing Maintenance Supplement
FDA (Devices) · 2026-10-07
- SevereBMC Medical Luna G3 APAP Devices Recalled for Retroactive Rework Reporting
FDA (Devices) · 2026-08-26
- LowFARASTAR Cardiac Ablation Generator Recall for Missing Catheter Information
FDA (Devices) · 2026-07-29
- ModerateFARASTAR Ablation Generator EU Medical Device Recall for Labeling Discrepancy
FDA (Devices) · 2026-07-29
- LowPenner bathing spa models recalled for lacking a unique device identifier
FDA (Devices) · 2026-03-18
Similar recalls
- ModerateStryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions
FDA (Devices) · 2014-12-24
- ModerateStryker Laparoscopic Manual Instruments Recalled for Sterilization Parameter Errors
FDA (Devices) · 2014-12-24
- ModerateStryker Laparoscopic Manual Instruments Recalled for Sterilization Instructions
FDA (Devices) · 2014-12-24
- ModerateStryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues
FDA (Devices) · 2014-12-24
- ModerateStryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error
FDA (Devices) · 2014-12-24
- ModerateStryker Laparoscopic Grasper Recalled Due to Sterilization Instructions
FDA (Devices) · 2014-12-24