Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 15, 2017
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient d
The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.
Parker Medical recalled Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with… - a moderate-severity action.
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with… was recalled by Parker Medical in March 15, 2017. Reason: The product was not functioning as intended. The ventilation to the patient was not disrupted, but the singl…. Check the official notice for the remedy. Verify recall #Z-1399-2017 with the FDA Devices before acting.
The recall
Parker Medical issued this moderate-severity FDA Devices recall-The product was not functioning as intended. The ventilation to the patient was not disrupted, but the singl….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- March 15, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1399-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1399-2017) was formally reported on March 15, 2017, with the manufacturer initiating the action on December 16, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Parker Medical is listed as the recalling firm, operating out of Highlands Ranch, CO. Federal records list the affected scope as 1,060 units.
The documented reason for this recall is: The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended. Distribution data in the federal record shows the product reached: Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee.. 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 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
1,060 units
Related Recalls
6
3 from same agency
Product description
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient during surgeries
Reason for recall
The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1399-2017 |
| Date reported | March 15, 2017 |
| Date initiated | December 16, 2016 |
| Recalling firm | Parker Medical |
| Firm location | Highlands Ranch, CO |
| Affected scope | 1,060 units |
| Distribution | Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee. |
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-1399-2017) 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? ▼
Parker Left Double Lumen Endobronchial Tube with Parker Flex-Tip (Parker Endo-Bronch with Flex Tip). Model Numbers: H-PFTDL-28-1, H-PFTDL-32-1, H-PFTDL-35-1, H-PFTDL-37-1, H-PFTDL-39-1, H-PFTDL-41-1. The product is an endotracheal tube with a double lumen for single lung isolation allowing for ventilation of one lung during a surgical procedure. Endotracheal tubes are used for intubating patients and used in conjunction with a ventilator to provide oxygen and anesthetic agents to the patient during surgeries. Recalled by Parker Medical. Units affected: 1,060 units.
Why was this product recalled? ▼
The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2017. Severity: Moderate. Recall number: Z-1399-2017.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution to CO, FL, IN, SC and TX. One VA consignee..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1399-2017) 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.
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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 March 15, 2017. 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.