Applied Medical's Inzii¿ 12/15mm Retrieval System — Class II medical device recall Z-0183-2014
Terminated recall by Applied Medical Resources Corp, reported 2013-11-20, distributed nationwide. Applied Medical is conducting a voluntary recall of the Inzii¿ 12/15mm retrieval system. During shipment, the
| Recall number | Z-0183-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Applied Medical Resources Corp, Rancho Santa Margarita, CA, United States |
| Recall initiated | 2013-10-21 |
| Classified | 2013-11-08 |
| Reported by FDA | 2013-11-20 |
| Terminated | 2014-09-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CL, CO, CZ, DE, DK, EC, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, LB, MX, MY, NL, NO, NZ, PE, PL, PT, SA, SE, SG, ZA |
| Quantity | 29,506 units |
| Reason classes | sterility |
| Model numbers | CD004 |
Product
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.
Reason for recall
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.