Severity
Moderate
FDA Devices recall · Reported March 31, 2021
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent t…
Cardinal Health 200, LLC recalled In-View Clear Leggings Sterile - a moderate-severity action.
In-View Clear Leggings Sterile was recalled by Cardinal Health 200, LLC in March 31, 2021. Reason: Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these prod…. Check the official notice for the remedy. Verify recall #Z-1300-2021 with the FDA Devices before acting.
The recall
Cardinal Health 200, LLC issued this moderate-severity FDA Devices recall-Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these prod….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1300-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1300-2021) was formally reported on March 31, 2021, with the manufacturer initiating the action on February 25, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Cardinal Health 200, LLC is listed as the recalling firm, operating out of Waukegan, IL. Federal records list the affected scope as 28417 units.
The documented reason for this recall is: Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and appl… Distribution data in the federal record shows the product reached: Distributed nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Distributed a…. 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 its category - 40,322 medical devices recalls on record
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
28417 units
Related Recalls
6
3 from same agency
In-View Clear Leggings Sterile
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1300-2021 |
| Date reported | March 31, 2021 |
| Date initiated | February 25, 2021 |
| Recalling firm | Cardinal Health 200, LLC |
| Firm location | Waukegan, IL |
| Affected scope | 28417 units |
| Distribution | Distributed nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV. Distributed also to Australia and… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
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.
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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 31, 2021. 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.