Sutter recalls specific models of single-use electrosurgical forceps due to incorrect sterilization labeling in package inserts. The error could lead to improper sterilization methods.
The label on the cardbox and the blister show the correct symbols for sterilization using irradiation and storage at 5 C to 40 C, the package insert (IFU) is labelled incorrectly. It shows the symbol for sterilization using Ethylene Oxide with the description for sterilization using irradiation.
Sutter is recalling specific models of single-use electrosurgical forceps because the package instructions incorrectly label sterilization methods. This could lead to improper sterilization if users follow the wrong instructions.
The package insert incorrectly shows Ethylene Oxide sterilization symbols instead of Irradiation. This could lead to improper sterilization if users follow the wrong instructions, but the instruments themselves are single-use and designed for safe surgical use.
Surgical professionals and hospitals using the recalled Sutter Swyng non-stick bipolar forceps models. The risk is low as the issue is a labeling error, not a safety hazard.
Check for the model numbers: 78 44 905 ST, 78 44 105 ST, 78 44 405 ST, 78 44 910 ST, 78 44 110 ST, 78 44 410 ST, 78 44 915 ST, 78 44 115 ST, 78 44 410 ST, 78 44 710 ST, 78 44 610 ST, 78 44 810 ST, 78 44 110 SL, 78 44 410 SL, 78 44 115 SL, 78 44 415 SL. These are single-use electrosurgical instruments sold for medical use.
Identify if your forceps have the listed model numbers: 78 44 905 ST, 78 44 105 ST, 78 44 405 ST, 78 44 910 ST, 78 44 110 ST, 78 44 410 ST, 78 44 915 ST, 78 44 115 ST, 78 44 410 ST, 78 44 710 ST, 78 44 610 ST, 78 44 810 ST, 78 44 110 SL, 78 44 410 SL, 78 44 115 SL, 78 44 415 SL.
The package insert incorrectly shows Ethylene Oxide sterilization symbols instead of Irradiation, which could lead to improper sterilization if users follow the wrong instructions.
Yes, the instruments are single-use and designed for safe surgical use. The issue is only with the labeling, not the physical safety of the instruments.
Check if your forceps have the listed model numbers. If they do, contact Sutter for more information.
We’ve drafted a message you can send Sutter to request your refund or repair — edit it as you like.
Subject: Recall Z-2744-2020 — Sutter Sutter Hello, I own a Sutter that is covered by recall Z-2744-2020 from Sutter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
