ModerateClass IIOngoing

FDA Devices recall · Reported July 16, 2025

VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE 63CM/45DEG/D0) VXSK0121 VXSK (180P RF WIRE 63CM/45DEG/D1) VXSK0122 VXSK (180P RF WIRE 63CM/55DEG/D0) VXSK0123 VXSK (180P RF WIRE 63CM/55DEG/D1) VXSK0124 VXSK (180P RF WIRE 63CM/90DEG/D0) VXSK0125 VXSK (230J RF WIRE 63CM/45DEG/D0) VXSK0111 VXSK (230J RF WIRE 63CM/45DE

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on July 16, 2025. Severity: Moderate. Recall number: Z-2103-2025.

Q: Where was the recalled product distributed?

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan..

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

Check the product description and recall number (Z-2103-2025) 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.

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst c…

Recall #: Z-2103-2025
Affected scope: 14,724
Initiated: June 10, 2025

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

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Boston Scientific Corporation recalled VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63C… - a moderate-severity action.

VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63C… was recalled by Boston Scientific Corporation in July 16, 2025. Reason: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Is…. Check the official notice for the remedy. Verify recall #Z-2103-2025 with the FDA Devices before acting.

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The recall

Boston Scientific Corporation issued this moderate-severity FDA Devices recall-Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Is….

Moderate
severity level: 15K units
affected scope: Class II
classification: July 16, 2025
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2103-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2103-2025) was formally reported on July 16, 2025, with the manufacturer initiating the action on June 10, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Boston Scientific Corporation is listed as the recalling firm, operating out of Saint Paul, MN. Federal records list the affected scope as 14,724.

The documented reason for this recall is: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.. 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

14,724

Related Recalls

3 from same agency

Product description

VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE 63CM/45DEG/D0) VXSK0121 VXSK (180P RF WIRE 63CM/45DEG/D1) VXSK0122 VXSK (180P RF WIRE 63CM/55DEG/D0) VXSK0123 VXSK (180P RF WIRE 63CM/55DEG/D1) VXSK0124 VXSK (180P RF WIRE 63CM/90DEG/D0) VXSK0125 VXSK (230J RF WIRE 63CM/45DEG/D0) VXSK0111 VXSK (230J RF WIRE 63CM/45DEG/D1) VXSK0112 VXSK (230P RF WIRE 63CM/45DEG/D0) VXSK0131 VXSK (230P RF WIRE 63CM/45DEG/D1) VXSK0132 VXSK (230P RF WIRE 63CM/55DEG/D0) VXSK0133 VXSK (230P RF WIRE 63CM/55DEG/D1) VXSK0134 VXSK (230P RF WIRE 81CM/45DEG/D0) VXSK0137 VXSK-180P RF WIRE 63CM/45DEG/D0 SHEATH VXSK0021 VXSK-180P RF WIRE 63CM/45DEG/D1 SHEATH VXSK0022 VXSK-180P RF WIRE 63CM/55DEG/D1 SHEATH VXSK0024 VXSK-180P RF WIRE 63CM/90DEG/D0 SHEATH VXSK0025 VXSK-230P RF WIRE 63CM/45DEG/D0 SHEATH VXSK0031 VXSK-230P RF WIRE 63CM/45DEG/D1 SHEATH VXSK0032 VXSK-230P RF WIRE 63CM/55DEG/D1 SHEATH VXSK0034

Reason for recall

Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.

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	Ongoing
Recall number	Z-2103-2025
Date reported	July 16, 2025
Date initiated	June 10, 2025
Recalling firm	Boston Scientific Corporation
Firm location	Saint Paul, MN
Affected scope	14,724
Distribution	Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.

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

Scale of Impact

14,724 units affected - limited or regional distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) ✓ This recall

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-2103-2025) 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 16, 2025. Severity: Moderate. Recall number: Z-2103-2025.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan..

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

Check the product description and recall number (Z-2103-2025) 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 July 16, 2025. 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.