Severity
Moderate
FDA Devices recall · Reported June 14, 2023
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that c…
C.r. Bard Inc recalled HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810,… - a moderate-severity action.
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810,… was recalled by C.r. Bard Inc in June 14, 2023. Reason: Some catheters had a manufacturing defect where the clear resealing label separating from the product foil po…. Check the official notice for the remedy. Verify recall #Z-1701-2023 with the FDA Devices before acting.
The recall
C.r. Bard Inc issued this moderate-severity FDA Devices recall-Some catheters had a manufacturing defect where the clear resealing label separating from the product foil po….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1701-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1701-2023) was formally reported on June 14, 2023, with the manufacturer initiating the action on April 20, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. C.r. Bard Inc is listed as the recalling firm, operating out of Covington, GA. Federal records list the affected scope as 308520 devices, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility. Distribution data in the federal record shows the product reached: Worldwide. 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.
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.
Severity
Moderate
Affected scope
308520 devices
Related Recalls
6
3 from same agency
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1701-2023 |
| Date reported | June 14, 2023 |
| Date initiated | April 20, 2023 |
| Recalling firm | C.r. Bard Inc |
| Firm location | Covington, GA |
| Affected scope | 308520 devices |
| Distribution | Worldwide |
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 June 14, 2023. 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.