Severity
Moderate
FDA Devices recall · Reported April 2, 2014
Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerP…
Bard Access Systems recalled PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated acces… - a moderate-severity action.
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated acces… was recalled by Bard Access Systems in April 2, 2014. Reason: Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however appro…. Check the official notice for the remedy. Verify recall #Z-1300-2014 with the FDA Devices before acting.
The recall
Bard Access Systems issued this moderate-severity FDA Devices recall-Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however appro….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1300-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1300-2014) was formally reported on April 2, 2014, with the manufacturer initiating the action on February 27, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Bard Access Systems is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as 777.
The documented reason for this recall is: Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port witho… Distribution data in the federal record shows the product reached: US Nationwide distribution including WA, KY, IL, and IA.. 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
777
Related Recalls
6
3 from same agency
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port without silicone suture plugs.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1300-2014 |
| Date reported | April 2, 2014 |
| Date initiated | February 27, 2014 |
| Recalling firm | Bard Access Systems |
| Firm location | Salt Lake City, UT |
| Affected scope | 777 |
| Distribution | US Nationwide distribution including WA, KY, IL, and IA. |
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 April 2, 2014. 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.