FDA Devices recall · Reported November 20, 2013
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.
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…
Applied Medical Resources Corp recalled Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Ba… - a moderate-severity action.
Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Ba… was recalled by Applied Medical Resources Corp in November 20, 2013. Reason: Applied Medical is conducting a voluntary recall of the Inzii¿ 12/15mm retrieval system. During shipment, the…. Check the official notice for the remedy. Verify recall #Z-0183-2014 with the FDA Devices before acting.
The recall
Applied Medical Resources Corp issued this moderate-severity FDA Devices recall-Applied Medical is conducting a voluntary recall of the Inzii¿ 12/15mm retrieval system. During shipment, the….
- Moderate
- severity level
- 30K units
- affected scope
- Class II
- classification
- November 20, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0183-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0183-2014 |
| Date reported | November 20, 2013 |
| Date initiated | October 21, 2013 |
| Recalling firm | Applied Medical Resources Corp |
| Firm location | Rancho Santa Margarita, CA |
| Affected scope | 29,506 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Lebanon, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0183-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026