Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 25, 2018
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.
Teleflex Medical Europe Ltd recalled Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 … - a moderate-severity action.
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 … was recalled by Teleflex Medical Europe Ltd in April 25, 2018. Reason: These one-way valves may disconnect at the joint between the two components that make up the device, which wo…. Check the official notice for the remedy. Verify recall #Z-1403-2018 with the FDA Devices before acting.
The recall
Teleflex Medical Europe Ltd issued this moderate-severity FDA Devices recall-These one-way valves may disconnect at the joint between the two components that make up the device, which wo….
- Moderate
- severity level
- 104K units
- affected scope
- Class II
- classification
- April 25, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1403-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1403-2018) was formally reported on April 25, 2018, with the manufacturer initiating the action on March 27, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Teleflex Medical Europe Ltd is listed as the recalling firm, operating out of Athlone. Federal records list the affected scope as 103910 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient. Distribution data in the federal record shows the product reached: US Nationwide in the states of AU, CA, NZ. 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, 6 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 - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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
103910 units
Related Recalls
6
6 from same agency
Product description
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
Reason for recall
These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1403-2018 |
| Date reported | April 25, 2018 |
| Date initiated | March 27, 2018 |
| Recalling firm | Teleflex Medical Europe Ltd |
| Firm location | Athlone |
| Affected scope | 103910 units |
| Distribution | US Nationwide in the states of AU, CA, NZ |
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-1403-2018) 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? ▼
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.. Recalled by Teleflex Medical Europe Ltd. Units affected: 103910 units.
Why was this product recalled? ▼
These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 25, 2018. Severity: Moderate. Recall number: Z-1403-2018.
Where was the recalled product distributed? ▼
Distribution: US Nationwide in the states of AU, CA, NZ.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1403-2018) 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.
Nationwide recalls with similar severity or category timing
Two federal-filing-derived peer sets for this notice, both outside the same recalling firm and filing state so the neighborhoods are not firm or geographic containment.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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 April 25, 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 August 2026.