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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87134

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

Open FDA event record

Event summary

Timeline bucket
January 07, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
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

13 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 13

Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Z-1085-2021
Recall number
Z-1085-2021
Initiated
January 07, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
29,810,665 total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Code information

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Distribution pattern

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.

device · product 2 of 13

Gown Isolation W/Ties Xl Ylw, SKU 1101PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Z-1086-2021
Recall number
Z-1086-2021
Initiated
January 07, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
29,810,665 total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Code information

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Distribution pattern

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.

device · product 3 of 13

Gown Isolation W/Ties Univ Blu, SKU 1200PG, 2200PG, 552200PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Z-1087-2021
Recall number
Z-1087-2021
Initiated
January 07, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
29,810,665 total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Code information

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Distribution pattern

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.

device · product 4 of 13

Gown Isolation W/Ties Xl Blue, SKU 2201PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Z-1088-2021
Recall number
Z-1088-2021
Initiated
January 07, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
29,810,665 total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Code information

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Distribution pattern

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.

device · product 5 of 13

Lab Coats SMS Large Blue, SKU 2202LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Z-1089-2021
Recall number
Z-1089-2021
Initiated
January 07, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
29,810,665 total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Code information

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Distribution pattern

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.

device · product 6 of 13

Lab Coats SMS X-Large Blue, SKU 2203LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Z-1090-2021
Recall number
Z-1090-2021
Initiated
January 07, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
29,810,665 total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Code information

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Distribution pattern

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.

device · product 7 of 13

Lab Coats SMS 2X-Large Blue, SKU 2204LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Z-1091-2021
Recall number
Z-1091-2021
Initiated
January 07, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
29,810,665 total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Code information

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Distribution pattern

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.

device · product 8 of 13

Lab Coats SMS Medium White, SKU 2301LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Z-1092-2021
Recall number
Z-1092-2021
Initiated
January 07, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
29,810,665 total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Code information

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Distribution pattern

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.

device · product 9 of 13

Lab Coats SMS Large White, SKU 2302LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Z-1093-2021
Recall number
Z-1093-2021
Initiated
January 07, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
29,810,665 total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Code information

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Distribution pattern

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.

device · product 10 of 13

Lab Coats SMS 2X-Large White, SKU 2304LC Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Z-1094-2021
Recall number
Z-1094-2021
Initiated
January 07, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
29,810,665 total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Code information

All lot numbers from 18KXBXXXXX to 20KXBXXXXX

Distribution pattern

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.

device · product 11 of 13

Gown Kendall Blue RG, SKU CT5000 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Z-1095-2021
Recall number
Z-1095-2021
Initiated
January 07, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
29,810,665 total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Code information

All lot numbers from 1901XXK to 2010XXK

Distribution pattern

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.

device · product 12 of 13

Gown Kendall Blue L, SKU CT5100, CT5101 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Z-1096-2021
Recall number
Z-1096-2021
Initiated
January 07, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
29,810,665 total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Code information

All lot numbers from 1901XXK to 2010XXK

Distribution pattern

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.

device · product 13 of 13

Gown Kendall Blue XXL, SKU CT5102 Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material where minimal fluid settings are expected.

Z-1097-2021
Recall number
Z-1097-2021
Initiated
January 07, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Cardinal Health 200, LLC
Quantity
29,810,665 total

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
foreign material

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats.

Code information

All lot numbers from 1901XXK to 2010XXK

Distribution pattern

Global Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA , WA, WI and WY including Puerto Rico; and OUS (countries) of: Australia, Canada, Chile, Israel, Japan, Netherlands, Saudi Arabia, Singapore, South Africa, Switzerland and United Arab Emirates.