ModerateClass IIOngoing

FDA Devices recall · Reported December 17, 2025

ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Non-sterile; CT5504T ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Non-sterile; CT5505T ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Non-sterile;

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on December 17, 2025. Severity: Moderate. Recall number: Z-0897-2026.

Q: Where was the recalled product distributed?

Distribution: Worldwide distribution - US Nationwide and the country of Canada..

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

Check the product description and recall number (Z-0897-2026) 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.

Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

Recall #: Z-0897-2026
Affected scope: 251,165 units
Initiated: November 12, 2025

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

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Cardinal Health 200, LLC recalled ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleev… - a moderate-severity action.

ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleev… was recalled by Cardinal Health 200, LLC in December 17, 2025. Reason: Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three…. Check the official notice for the remedy. Verify recall #Z-0897-2026 with the FDA Devices before acting.

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The recall

Cardinal Health 200, LLC issued this moderate-severity FDA Devices recall-Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three….

Moderate
severity level: 251K units
affected scope: Class II
classification: December 17, 2025
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0897-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0897-2026) was formally reported on December 17, 2025, with the manufacturer initiating the action on November 12, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Cardinal Health 200, LLC is listed as the recalling firm, operating out of Waukegan, IL. Federal records list the affected scope as 251,165 units, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the country of Canada.. 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

251,165 units

Related Recalls

3 from same agency

Product description

ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Non-sterile; CT5504T ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Non-sterile; CT5505T ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Non-sterile; DP5001GT ChemoPlus Full Coverage Gown, Open Back, Large, medium Blue, Non- sterile; DP5002GT ChemoPlus Full Coverage Gown, Open Back, Extra Large, medium Blue, Non-sterile; DP5003GT ChemoPlus Full Coverage Gown, Open Back, Medium, medium Blue, Non-sterile; DP5004GT ChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, medium Blue, Non-sterile; CT5500TS ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Sterile; CT5502TS ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503TS ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Sterile; CT5504TS ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Sterile; CT5505TS ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Sterile;

Reason for recall

Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

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-0897-2026
Date reported	December 17, 2025
Date initiated	November 12, 2025
Recalling firm	Cardinal Health 200, LLC
Firm location	Waukegan, IL
Affected scope	251,165 units
Distribution	Worldwide distribution - US Nationwide 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

251,165 units units affected - multi-state distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) ✓ This recall

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-0897-2026) 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? ▼

Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on December 17, 2025. Severity: Moderate. Recall number: Z-0897-2026.

Where was the recalled product distributed? ▼

Distribution: Worldwide distribution - US Nationwide and the country of Canada..

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

Check the product description and recall number (Z-0897-2026) 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 December 17, 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.