“Cardinal Health Lab Coats Blue: Potential for Rips and Tears in Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63442-cardinal-health-lab-coats-blue-potential-for-rips-and-tears. Based on FDA recall #Z-1090-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1090-2021%22&limit=1).
Cardinal Health 200, LLC recalled Lab Coats and gowns due to potential rips, holes, or open seams that could compromise barrier protection. The Food and Drug Administration announced the voluntary Class II recall on January 7, 2021.
The gowns and lab coats may have rips, holes, tears, incomplete or open seams, staining, foreign material, or debris. These defects pose a risk of compromised minimal barrier protection against microorganisms and body fluids.
Context
GovInfoNow's records show Cardinal Health 200, LLC has issued 59 other recalls since June 27, 2017. Other recent recalls of similar products include Presource Convenience Kits (August 10, 2026), Presource Gyn Laparoscopy Kits (August 18, 2026), and Presource Packs with Microstream Components (August 19, 2026). Other recent recalls of similar products include Covidien Dermalon 4-0 Blue Sutures (June 24, 2026), Covidien Surgipro II S8698GX (June 24, 2026), and Covidien Surgipro SP-623 Sutures (June 24, 2026).
How to tell if you have this one
Check for blue lab coats with SKU 2203LC. The product was sold from lot numbers 18KXBXXXXX to 20KXBXXXXX.
Brand
Cardinal Health
Category
Medical device
FDA recall event · 13 products
All 13 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
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.
Recall number
Product, codes & lots
Z-1085-2021
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.; All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Z-1086-2021
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.; All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Z-1087-2021
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.; All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Z-1088-2021
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.; All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Z-1089-2021
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.; All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Z-1090-2021
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.; All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Z-1091-2021
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.; All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Z-1092-2021
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.; All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Z-1093-2021
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.; All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Z-1094-2021
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.; All lot numbers from 18KXBXXXXX to 20KXBXXXXX
Z-1095-2021
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.; All lot numbers from 1901XXK to 2010XXK
Z-1096-2021
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.; All lot numbers from 1901XXK to 2010XXK
Z-1097-2021
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.; All lot numbers from 1901XXK to 2010XXK
Based on the official FDA remedy
What to do — step by step
Check for Rips or Tears
Inspect the gown for rips, holes, or tears that could compromise protection during medical use.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 45 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1090-2021 (January 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1090-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.