Severity
Moderate
ModerateClass IITerminated
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0183-2014) was formally reported on November 20, 2013, with the manufacturer initiating the action on October 21, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Applied Medical Resources Corp is listed as the recalling firm, operating out of Rancho Santa Margarita, CA. Federal records list the affected scope as 29,506 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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, Ita…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
29,506 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Applied Medical Resources Corp. Units affected: 29,506 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2013. Severity: Moderate. Recall number: Z-0183-2014.
Where was the recalled product distributed? ▼
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, Malaysia, Mexico, New Zealand, Netherlands, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, United Arab Emirates, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0183-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 20, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.