Cook Medical Recalls LapSac Introducer Sets Due to Insufficient Reprocessing Instructions
Cook Medical is voluntarily recalling 335 LapSac Introducer Sets because the provided reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.
What this means for you
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 describes a documentation deficiency (insufficient reprocessing instructions) rather than a direct contamination or structural defect, and no injuries or illnesses are reported. This aligns with the rubric for moderate severity involving labeling or documentation issues.
Plain-English summary
Cook Medical is initiating a voluntary recall of 335 units of the LapSac Introducer Set, Bag, Extraction. These products are supplied sterilized by ethylene oxide gas in peel-open packages and are used to aid in the introduction of a LapSac during endoscopic surgical procedures.
The recall is being conducted because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. The affected lots were manufactured between January 2012 and August 2015 and are identified by Catalog Number 054300 and GPN G15771.
The products were distributed worldwide, including nationwide in the United States and in 26 other countries. Healthcare facilities and distributors should stop using the affected products and contact Cook Medical for further instructions regarding the return or replacement of the units.
The recalled product
- Product
- LapSac Introducer Set, Bag, Extraction, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to aid in the introduction of a LapSac during endoscopic surgical procedures.
- Manufacturer
- Cook Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Cook 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 6 products in this recall →Related recalls
Same manufacturer · Cook Inc.
See all →- HighSkinny Needle with Chiba Tip recalled for debris contamination
FDA (Devices) · 2021-12-29
- HighCook Flexor Check-Flo Introducer recalled for size mislabeling
FDA (Devices) · 2021-12-22
- ModerateFlexor Check-Flo Introducer Recalled for Mislabeled Caliber Size
FDA (Devices) · 2021-12-22
- HighTransseptal Needles Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
- HighTransseptal Needle with Catheter Recalled Due to Rust Contamination Risk
FDA (Devices) · 2021-11-24
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02