Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 10, 2013
Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the p
Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the pack…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Merit Medical Systems, Inc. recalled Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combi… - a moderate-severity action.
Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combi… was recalled by Merit Medical Systems, Inc. in July 10, 2013. Reason: Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between t…. Check the official notice for the remedy. Verify recall #Z-1660-2013 with the FDA Devices before acting.
The recall
Merit Medical Systems, Inc. issued this moderate-severity FDA Devices recall-Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between t….
- Moderate
- severity level
- Class II
- classification
- July 10, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1660-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1660-2013) was formally reported on July 10, 2013, with the manufacturer initiating the action on November 21, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Merit Medical Systems, Inc. is listed as the recalling firm, operating out of Chester, VA. Federal records list the affected scope as 134 trays.
The documented reason for this recall is: Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of t… Distribution data in the federal record shows the product reached: U.S. Military Hospital on base in Landstuhl, Germany. 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
134 trays
Related Recalls
6
3 from same agency
Product description
Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.
Reason for recall
Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1660-2013 |
| Date reported | July 10, 2013 |
| Date initiated | November 21, 2012 |
| Recalling firm | Merit Medical Systems, Inc. |
| Firm location | Chester, VA |
| Affected scope | 134 trays |
| Distribution | U.S. Military Hospital on base in Landstuhl, Germany |
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-1660-2013) 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? ▼
Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural tray is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses. Contained within the tray are hand controller sheaths which are intended to enable increased flow control (when compared to hand injection) but with the feel of a hand syringe. It provides more control over the total volume delivered by allowing the physician to adjust contrast delivery during the injection and monitor total volume delivered to the patient.. Recalled by Merit Medical Systems, Inc.. Units affected: 134 trays.
Why was this product recalled? ▼
Custom Procedural trays contain Medrad Hand Controller Sheaths which were recalled because the seal between the white polyethylene and the clear plastic may be missing on the package resulting in a potential breach of the sterility of this accessory.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2013. Severity: Moderate. Recall number: Z-1660-2013.
Where was the recalled product distributed? ▼
Distribution: U.S. Military Hospital on base in Landstuhl, Germany.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1660-2013) 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 July 10, 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.