ModerateClass IITerminated

FDA Devices recall · Reported July 27, 2016

Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on July 27, 2016. Severity: Moderate. Recall number: Z-2243-2016.

Q: Where was the recalled product distributed?

Distribution: US Nationwide Distribution in the states of KY, MO, FL, TN, and TX..

Q: 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.

Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressu…

Recall #: Z-2243-2016
Affected scope: 5,500 units
Initiated: June 2, 2016

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

Parker Medical recalled Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The pr… - a moderate-severity action.

Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The pr… was recalled by Parker Medical in July 27, 2016. Reason: Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal…. Check the official notice for the remedy. Verify recall #Z-2243-2016 with the FDA Devices before acting.

The recall

Parker Medical issued this moderate-severity FDA Devices recall-Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal….

Moderate
severity level: 6K units
affected scope: Class II
classification: July 27, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2243-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 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.

Product description

Parker Trach-Vac Endotracheal Tubes. Tyvek pouches, 10 per box. Product Usage: The product is an endotracheal tube with sub-glottic suction channel to remove secretions. It is used for intubating patients and used with a ventilator to provide oxygen or anesthetic agents to the patient.

Reason for recall

Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2243-2016
Date reported	July 27, 2016
Date initiated	June 2, 2016
Recalling firm	Parker Medical
Firm location	Highlands Ranch, CO
Affected scope	5,500 units
Distribution	US Nationwide Distribution in the states of KY, MO, FL, TN, and TX.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

5,500 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2243-2016) 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? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 27, 2016. Severity: Moderate. Recall number: Z-2243-2016.

Where was the recalled product distributed? ▼

Distribution: US Nationwide Distribution in the states of KY, MO, FL, TN, and TX..

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

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Novel Laboratories Recalls Zolpidem Tartr… 2016-07-27 Emson Recalls UComfy Heat Wraps Due to Bu… 2016-07-27 0.03% Bupivacaine HCl (Preservative Free)… 2016-07-27 0.05 mg/mL Morphine Sulfate and 0.0625% B… 2016-07-27

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

AngioDynamics Soft Vu Omni Flush Angiogra… 2016-07-27 Toshiba America Medical Systems Angio Wor… 2016-07-27 RayStation 3.0, RayStation 3.5, RayStatio… 2016-07-27 HX2" Temperature Management Systems; … 2016-07-27

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported July 27, 2016. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026