Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 29, 2015
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.
Catheter Research, Inc recalled HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hyste… - a moderate-severity action.
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hyste… was recalled by Catheter Research, Inc in April 29, 2015. Reason: HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the …. Check the official notice for the remedy. Verify recall #Z-1481-2015 with the FDA Devices before acting.
The recall
Catheter Research, Inc issued this moderate-severity FDA Devices recall-HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the ….
- Moderate
- severity level
- 880 units
- affected scope
- Class II
- classification
- April 29, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1481-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1481-2015) was formally reported on April 29, 2015, with the manufacturer initiating the action on April 7, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Catheter Research, Inc is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 880 units.
The documented reason for this recall is: HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa. Distribution data in the federal record shows the product reached: Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None. 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
880 units
Related Recalls
6
3 from same agency
Product description
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
Reason for recall
HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1481-2015 |
| Date reported | April 29, 2015 |
| Date initiated | April 7, 2015 |
| Recalling firm | Catheter Research, Inc |
| Firm location | Indianapolis, IN |
| Affected scope | 880 units |
| Distribution | Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None |
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-1481-2015) 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? ▼
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.. Recalled by Catheter Research, Inc. Units affected: 880 units.
Why was this product recalled? ▼
HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 29, 2015. Severity: Moderate. Recall number: Z-1481-2015.
Where was the recalled product distributed? ▼
Distribution: Domestic: MN, CA, OH, IL, FL, MA, WI, VA Foreign: None DOD/VA: None.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1481-2015) 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 April 29, 2015. 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.