Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported July 24, 2019
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label inform…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Teleflex Medical recalled RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device - a low-severity action.
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device was recalled by Teleflex Medical in July 24, 2019. Reason: The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not af…. Check the official notice for the remedy. Verify recall #Z-1975-2019 with the FDA Devices before acting.
The recall
Teleflex Medical issued this low-severity FDA Devices recall-The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not af….
- Low
- severity level
- Class III
- classification
- July 24, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1975-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1975-2019) was formally reported on July 24, 2019, with the manufacturer initiating the action on January 14, 2019. It is classified under Low severity (Class III), with a current status of Terminated. Teleflex Medical is listed as the recalling firm, operating out of Morrisville, NC. Federal records list the affected scope as 76725 US eaches.
The documented reason for this recall is: The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by thi… Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador.. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
76725 US eaches
Related Recalls
6
3 from same agency
Product description
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device
Reason for recall
The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1975-2019 |
| Date reported | July 24, 2019 |
| Date initiated | January 14, 2019 |
| Recalling firm | Teleflex Medical |
| Firm location | Morrisville, NC |
| Affected scope | 76725 US eaches |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador. |
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-1975-2019) 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? ▼
RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device. Recalled by Teleflex Medical. Units affected: 76725 US eaches.
Why was this product recalled? ▼
The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2019. Severity: Low. Recall number: Z-1975-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) and countries of: Canada, Bolivia, Guatemala, Jamaica, Peru, Trinidad, and El Salvador..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1975-2019) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 24, 2019. 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.