CriticalClass ITerminated

FDA Devices recall · Reported July 27, 2016

AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on July 27, 2016. Severity: Critical. Recall number: Z-2096-2016.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution -- USA, to the states of TX, UT, PA, CA, VT, MA, WA, VA, NY, MD, and CT; and, the country of CANADA..

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.

Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.

Recall #: Z-2096-2016
Affected scope: 167
Initiated: June 1, 2016

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

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Stryker Sustainability Solutions recalled AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203 - a critical-severity action.

AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203 was recalled by Stryker Sustainability Solutions in July 27, 2016. Reason: Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the…. Check the official notice for the remedy. Verify recall #Z-2096-2016 with the FDA Devices before acting.

The recall

Stryker Sustainability Solutions issued this critical-severity FDA Devices recall-Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the….

Critical
severity level: 167 units
affected scope: Class I
classification: July 27, 2016
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2096-2016 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 high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203

Reason for recall

Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Critical (Class I)
Status	Terminated
Recall number	Z-2096-2016
Date reported	July 27, 2016
Date initiated	June 1, 2016
Recalling firm	Stryker Sustainability Solutions
Firm location	Tempe, AZ
Affected scope	167
Distribution	Worldwide Distribution -- USA, to the states of TX, UT, PA, CA, VT, MA, WA, VA, NY, MD, and CT; and, the country of CANADA.

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

Scale of Impact

167 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-2096-2016) 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.
This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼

AngioDynamics Soft Vu Omni Flush Angiographic Catheter Model Number: 10732203. Recalled by Stryker Sustainability Solutions. Units affected: 167.

Why was this product recalled? ▼

Product defect; tip of two (2) Angiographic Catheters model # 10732203 broke off, prior to being used on the patient.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 27, 2016. Severity: Critical. Recall number: Z-2096-2016.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution -- USA, to the states of TX, UT, PA, CA, VT, MA, WA, VA, NY, MD, and CT; and, the country of CANADA..

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 (Critical), closest by report date among other firms and states.

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Similar Medical Devices · nearest report date

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

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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