Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Laparoscopy CDS Recalled by Medline Industries, Inc. Due to One manufacturing lot of a non-sterile pack was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medline Industries, Inc. directly.
Affected Products
Laparoscopy CDS
Quantity: 15 kits
Why Was This Recalled?
One manufacturing lot of a non-sterile pack was assembled with a non-sterile component labeled sterile (kit component #80532NS). The non-sterile component 80532NS was supposed to be placed inside the sterile portion of the pack where it would subsequently be exposed to the ethylene oxide sterilization process. However, the component was not placed in the sterile portion of the pack during assembly and was never exposed to the sterilization process. Component 80532NS was inadvertently released non-sterile. Component 80532NS is packaged by Medline and is an Anti-fog kit that contains 1 bottle of 6g Anti-Fog solution and an adhesive backed sponge.
Where Was This Sold?
This product was distributed to 2 states: CA, NM
About Medline Industries, Inc.
Medline Industries, Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report