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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87431

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 25, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cardinal Health 200, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

In-View Clear Leggings Sterile

Z-1300-2021
Recall number
Z-1300-2021
Initiated
February 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
28417 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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).

Distribution pattern

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.

device · product 2 of 5

In-View Clear Leggings Sterile Non-Sterile

Z-1301-2021
Recall number
Z-1301-2021
Initiated
February 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
1020 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Catalog Number 8430N; Lot number's: 3290DR1 and 3300DR1

Distribution pattern

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.

device · product 3 of 5

In-View Clear Leggings Bulk Non-Sterile

Z-1302-2021
Recall number
Z-1302-2021
Initiated
February 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
21343 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Catalog Number 8430NA; Lot number's: 2460DR2, 2550DR1, 2660DR1, 2470DR2, 2580DR1, 2690DR1, 2480DR2, 2580DR2, 2720DR1, 2520DR1, 2600DR1, 2730DR1, 2530DR1, 2600DR1, 3290DR1, 2540DR1, 2610DR1 3310DR1, 2540DR2, 2650DR1, 3440DR1

Distribution pattern

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.

device · product 4 of 5

Femoral Angiography Drape Sterile

Z-1303-2021
Recall number
Z-1303-2021
Initiated
February 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
936 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Catalog Number 29560; Lot number's: 20LQR067 (expiration date: 2025-11-01) and 20MQR023 (expiration date: 2025-12-01)

Distribution pattern

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.

device · product 5 of 5

Femoral Angiography Drape Bulk Non-Sterile

Z-1304-2021
Recall number
Z-1304-2021
Initiated
February 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Cardinal Health 200, LLC
Quantity
83213 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Catalog Number 29560NC; Lot number's: 2450ER1, 2660ER1, 2960ER1, 2450ER2, 2660ER2, 2960ER2, 2460ER1, 2670ER1, 2970ER1, 2460ER2, 2670ER2, 2970ER2, 2470ER1, 2690ER1, 3030ER1, 2470ER2, 2690ER2, 3030ER2, 2480ER1, 2720ER1, 3040ER1, 2480ER2, 2720ER2, 3040ER2, 2510ER1, 2730ER1, 3080ER2, 2510ER2, 2730ER2, 3090ER1, 2520ER1, 2740ER1, 3090ER2, 2520ER2, 2740ER2, 3100ER1, 2530ER1, 2750ER1, 3100ER2, 2530ER2, 2750ER2, 3150ER1, 2540ER1, 2760ER1, 3160ER1, 2600ER2, 2760ER2, 3170ER1, 2610ER1, 2820ER1, 3180ER1, 2610ER2, 2820ER2, 3210ER1, 2620ER1, 2830ER1, 3290FR1, 2620ER2, 2830ER2, 3490FR1, 2650ER1, 2860ER1, 2650ER2, 2950ER2

Distribution pattern

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.