ModerateClass IITerminated

FDA Devices recall · Reported November 26, 2014

AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on November 26, 2014. Severity: Moderate. Recall number: Z-0215-2015.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CT, FL, GA, IN, KY, LA, MA, MI, MO, NC, NJ, NY OH, OR, PA, SC, TN, TX, VA, and WA and the countries of Belgium, Hong Kong, India, Japan, Panama and Singapore..

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.

There is a possibility the sterile packaging may fail before the expiration date specified on the package.

Recall #: Z-0215-2015
Affected scope: 3530 units
Initiated: March 24, 2014

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

Verify with FDA Devices →

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Soma Access Systems LLC recalled AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labele… - a moderate-severity action.

AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labele… was recalled by Soma Access Systems LLC in November 26, 2014. Reason: There is a possibility the sterile packaging may fail before the expiration date specified on the package.. Check the official notice for the remedy. Verify recall #Z-0215-2015 with the FDA Devices before acting.

The recall

Soma Access Systems LLC issued this moderate-severity FDA Devices recall-There is a possibility the sterile packaging may fail before the expiration date specified on the package..

Moderate
severity level: 4K units
affected scope: Class II
classification: November 26, 2014
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0215-2015 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

AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.

Reason for recall

There is a possibility the sterile packaging may fail before the expiration date specified on the package.

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-0215-2015
Date reported	November 26, 2014
Date initiated	March 24, 2014
Recalling firm	Soma Access Systems LLC
Firm location	Greenville, SC
Affected scope	3530 units
Distribution	Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CT, FL, GA, IN, KY, LA, MA, MI, MO, NC, NJ, NY OH, OR, PA, SC, TN, TX, VA, and WA and the countries of Belgium, Hong Kong, India, Japan, Panama and Singapore.

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

Scale of Impact

3530 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-0215-2015) 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? ▼

There is a possibility the sterile packaging may fail before the expiration date specified on the package.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 26, 2014. Severity: Moderate. Recall number: Z-0215-2015.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CT, FL, GA, IN, KY, LA, MA, MI, MO, NC, NJ, NY OH, OR, PA, SC, TN, TX, VA, and WA and the countries of Belgium, Hong Kong, India, Japan, Panama and Singapore..

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.

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This recall: FDA Devices, reported November 26, 2014. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026