CLASS II Device recall · Reported 31 Mar 2021 · FDA Enforcement Report
In-View Clear Leggings Sterile recalled by Cardinal Health 200
Cardinal Health 200 is recalling In-View Clear Leggings Sterile, distributed nationwide in the US. The recall was initiated on 25 Feb 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1300-2021
- FDA event ID
- 87431
- Recalling firm
- Cardinal Health 200, Waukegan, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Feb 2021
- FDA classified
- 24 Mar 2021
- Reported
- 31 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 25 Feb 2021 | Recall initiated by company | |
| 24 Mar 2021 | Classified by FDA | +27 days |
| 31 Mar 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
In-View Clear Leggings Sterile
Where it was distributed
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 Canada.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Catalog Number 8430; Lot number's: 20JKS003 (expiration date:2025-09-01), 20JKS004 (expiration date:2025-09-01), 20JKS005 (expiration date:2025-09-01), 20KKS047 (expiration date:2025-10-01), 20KKS050 (expiration date:2025-10-01), 20LKS63 (expiration date:2025-11-01), 20LKS075 (expiration date:2025-11-01), and 20MKS003 (expiration date:2025-12-01).
Where was it sold?
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 Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 87431| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | In-View Clear Leggings Sterile Non-Sterile recalled | Cardinal Health 200 | Foreign Material | Nationwide | |
| CLASS II | Femoral Angiography Drape Bulk Non-Sterile recalled | Cardinal Health 200 | Foreign Material | Nationwide | |
| CLASS II | Femoral Angiography Drape Sterile recalled by Cardinal Health 200 | Cardinal Health 200 | Foreign Material | Nationwide | |
| CLASS II | In-View Clear Leggings Bulk Non-Sterile recalled by Cardinal Health 200 | Cardinal Health 200 | Foreign Material | Nationwide |
More recalls from Cardinal Health 200
All 283| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
| Device | CLASS II | Presource Packs Containing CliniClean Pericare Wipes within recalled | Cardinal Health 200 | Other | Nationwide |
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| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |