Sklar Instruments recalls 12 sterile medical procedure kits with packaging issues that could breach the sterile barrier. Affected kits include Yankauer suction tubes and Frazier tubes with specific model numbers and lot codes.
Reports of various packaging issues that may result in a breach of the sterile barrier.
Sklar Instruments is recalling 12 different sterile medical procedure kits due to packaging issues that might breach the sterile barrier. This could lead to infections during medical procedures if the kits are used without a properly sealed barrier.
The packaging may not seal properly, potentially allowing contamination. This could lead to infections if the sterile barrier is compromised during medical procedures.
Healthcare professionals and medical facilities that use these sterile kits for procedures. The risk is low as the issue involves packaging integrity but not immediate harm.
Check for model numbers 96-4176 to 96-5494 on the kits. Look for lot codes FSS4 or FSS5 on the packaging. These kits were sold with specific UDI/DI numbers and lot codes.
Inspect the kit for lot codes FSS4 or FSS5 on the packaging.
If you have a kit with lot codes FSS4 or FSS5, stop using it immediately to avoid potential contamination.
The affected kits include ECONO STERILE Yankauer suction tubes (models 96-4176 to 96-4177) and Frazier tubes (models 96-5434 to 96-5494) with lot codes FSS4 or FSS5.
Check for model numbers 96-4176 to 96-5494 and lot codes FSS4 or FSS5 on the packaging. These specific kits were recalled due to packaging issues.
No action is needed if your kit does not have model numbers 96-4176 to 96-5494 or lot codes FSS4 or FSS5.
We’ve drafted a message you can send Sklar Instruments to request your refund or repair — edit it as you like.
Subject: Recall Z-0938-2025 — Sklar Instruments Sklar Instruments Hello, I own a Sklar Instruments that is covered by recall Z-0938-2025 from Sklar Instruments. 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.
