ModerateClass IITerminated

FDA Devices recall · Reported March 8, 2017

SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on March 8, 2017. Severity: Moderate. Recall number: Z-1395-2017.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay..

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

Check the product description and recall number (Z-1395-2017) 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.

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.

Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.

Recall #: Z-1395-2017
Affected scope: 538 units
Initiated: October 25, 2016

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

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Med-el Elektromedizinische Gereate, Gmbh recalled SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part … - a moderate-severity action.

SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part … was recalled by Med-el Elektromedizinische Gereate, Gmbh in March 8, 2017. Reason: Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.. Check the official notice for the remedy. Verify recall #Z-1395-2017 with the FDA Devices before acting.

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The recall

Med-el Elektromedizinische Gereate, Gmbh issued this moderate-severity FDA Devices recall-Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing..

Moderate
severity level: 538 units
affected scope: Class II
classification: March 8, 2017
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1395-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1395-2017) was formally reported on March 8, 2017, with the manufacturer initiating the action on October 25, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Med-el Elektromedizinische Gereate, Gmbh is listed as the recalling firm, operating out of Innsbruck, N/A. Federal records list the affected scope as 538 units.

The documented reason for this recall is: Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdo…. 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

538 units

Related Recalls

3 from same agency

Product description

SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.

Reason for recall

Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.

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-1395-2017
Date reported	March 8, 2017
Date initiated	October 25, 2016
Recalling firm	Med-el Elektromedizinische Gereate, Gmbh
Firm location	Innsbruck, N/A
Affected scope	538 units
Distribution	Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay.

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

Scale of Impact

538 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-1395-2017) 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? ▼

Why was this product recalled? ▼

Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on March 8, 2017. Severity: Moderate. Recall number: Z-1395-2017.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution - US Nationwide in the states of CA, NC and TX; and the countries of Belgium, Belarus, Canada, France, Germany, Hong Kong, Israel, Netherlands, Philippines, Poland, Portugal, Turkey, United Kingdom, and Uruguay..

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

Check the product description and recall number (Z-1395-2017) 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 8, 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.