ModerateClass IITerminated

FDA Devices recall · Reported March 2, 2016

EndoVive 3s Low Profile Balloon Kits Part Number: M00548720 (XMD P/N 70-0050-718) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on March 2, 2016. Severity: Moderate. Recall number: Z-0957-2016.

Q: Where was the recalled product distributed?

Distribution: Nationwide distribution to MA only..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0957-2016) 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.

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.

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile…

Recall #: Z-0957-2016
Affected scope: 76
Initiated: December 23, 2015

Compiled from official public sources by the editorial team. · Updated August 2026

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Xeridiem Mediem Medical Devices Inc recalled EndoVive 3s Low Profile Balloon Kits Part Number: M00548720 (XMD P/N 70-0050-718) The… - a moderate-severity action.

EndoVive 3s Low Profile Balloon Kits Part Number: M00548720 (XMD P/N 70-0050-718) The… was recalled by Xeridiem Mediem Medical Devices Inc in March 2, 2016. Reason: A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a dela…. Check the official notice for the remedy. Verify recall #Z-0957-2016 with the FDA Devices before acting.

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The recall

Xeridiem Mediem Medical Devices Inc issued this moderate-severity FDA Devices recall-A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a dela….

Moderate
severity level: 76 units
affected scope: Class II
classification: March 2, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0957-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0957-2016) was formally reported on March 2, 2016, with the manufacturer initiating the action on December 23, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Xeridiem Mediem Medical Devices Inc is listed as the recalling firm, operating out of Tucson, AZ. Federal records list the affected scope as 76.

The documented reason for this recall is: A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding s… Distribution data in the federal record shows the product reached: Nationwide distribution to MA only.. 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 the database

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

Related Recalls

3 from same agency

Product description

EndoVive 3s Low Profile Balloon Kits Part Number: M00548720 (XMD P/N 70-0050-718) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.

Reason for recall

A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric contents to leak out of the device in some instances.

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-0957-2016
Date reported	March 2, 2016
Date initiated	December 23, 2015
Recalling firm	Xeridiem Mediem Medical Devices Inc
Firm location	Tucson, AZ
Affected scope	76
Distribution	Nationwide distribution to MA only.

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

Scale of Impact

76 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-0957-2016) 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 March 2, 2016. Severity: Moderate. Recall number: Z-0957-2016.

Where was the recalled product distributed? ▼

Distribution: Nationwide distribution to MA only..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0957-2016) 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 2, 2016. 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.