Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Recalled by Applied Medical Resources Corp Due to Applied Medical is conducting a voluntary recall of...
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 Applied Medical Resources Corp directly.
Affected Products
Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.
Quantity: 29,506 units
Why Was This Recalled?
Applied Medical is conducting a voluntary recall of the Inzii¿ 12/15mm retrieval system. During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. The likelihood of this situation to occur and result in patient harm is highly unlikely; however, out of an abundance of caution for patient safety and a commitmen
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Applied Medical Resources Corp
Applied Medical Resources Corp has 30 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report