Severity
Moderate
FDA Devices recall · Reported December 5, 2018
Instructions for Use booklets were not included on the outer pouch
Numed Inc recalled Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recomm… - a moderate-severity action.
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recomm… was recalled by Numed Inc in December 5, 2018. Reason: Instructions for Use booklets were not included on the outer pouch. Check the official notice for the remedy. Verify recall #Z-0510-2019 with the FDA Devices before acting.
The recall
Numed Inc issued this moderate-severity FDA Devices recall-Instructions for Use booklets were not included on the outer pouch.
Sourced from official FDA Devices enforcement records. Verify recall #Z-0510-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0510-2019) was formally reported on December 5, 2018, with the manufacturer initiating the action on October 17, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Numed Inc is listed as the recalling firm, operating out of Hopkinton, NY. Federal records list the affected scope as 100 units.
The documented reason for this recall is: Instructions for Use booklets were not included on the outer pouch Distribution data in the federal record shows the product reached: US distribution in the state of PA. 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 - 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.
Where this recall sits in its category - 40,422 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.
Severity
Moderate
Affected scope
100 units
Related Recalls
6
0 from same agency
Multi-Track Angiographic Catheter (MMTA) Product Code: MMTA05100 Product Usage: Recommended for use in catheterization for angiography of cardiovascular vessels and I or chambers. It can be used for injection of contrast medium and pressure measurement in any chamber or vessel.
Instructions for Use booklets were not included on the outer pouch
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0510-2019 |
| Date reported | December 5, 2018 |
| Date initiated | October 17, 2018 |
| Recalling firm | Numed Inc |
| Firm location | Hopkinton, NY |
| Affected scope | 100 units |
| Distribution | US distribution in the state of PA |
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.
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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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 December 5, 2018. 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.