Lower riskMedical device recall · FDA · Published October 31, 2018
Cardinal Health Protexis Neoprene Surgical Gloves Recall: Incorrect Breakthrough Times
Cardinal Health recalls Protexis Neoprene surgical gloves size 8.5 due to incorrect labeling of chemotherapy drug breakthrough times. This could affect patient safety during surgery.
Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error.
Take action
Contact the company
📍Recalling firmCardinal Health 200, LLC3651 Birchwood Dr · Waukegan, IL 60085-8337
“Cardinal Health Protexis Neoprene Surgical Gloves Recall: Incorrect Breakthrough Times.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69533-cardinal-health-protexis-neoprene-surgical-gloves-recall-incorrect-breakthrough-times. Based on FDA recall #Z-0637-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0637-2019%22&limit=1).
Cardinal Health 200, LLC recalled Protexis Neoprene Surgical Gloves, Size 8.5, due to incorrect labeling of breakthrough times for chemotherapy drugs, the FDA said on Oct. 31, 2018. The recall affects 1,475,095 pairs distributed worldwide.
Lot Numbers: TS18060015, TS18060329, TS18070121, TS18070314, TS18080034, TS18080352, and TS18090219
Quantity: 1,475,095 pairs
The hazard
The labeling on the primary packaging states incorrect breakthrough (permeation) times for the chemotherapy drugs Carmustine and Thiotepa. Additionally, breakthrough times for Mitomycin were added to the label in error.
Context
GovInfoNow's records show Cardinal Health 200, LLC has 59 other recalls on record since 2017-06-27. Other recent recalls of similar products include Presource Convenience Kits Recall: Contaminated Applicators Risk Infection (2026-08-10), Performance Pro Blue Nitrile Gloves Recall: Defect Risk (2026-08-14), Medline Convenience Kits Recall: Risk of Skin Infection from Open Seal Applicators (2026-07-20), and Halyard Purezero Ultraviolet Nitrile Exam Gloves Recall: Chemical Permeation Failure (2026-04-13).
How to tell if you have this one
Check for the product code 2D73DP85 and lot numbers TS18060015, TS18060329, TS18070121, TS18070314, TS18080034, TS18080352, or TS18090219. The gloves are powder-free, light brown, and size 8.5.
Brand
Cardinal Health
Category
Medical device
FDA recall event · 8 products
All 8 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
Terminated
Distribution
Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and to countries of: Austria, Belgium, Canada, Chile, Costa Rica, France, Germany, Italy, Luxembourg, Martinique, Monaco, Netherlands, Poland, Reunion, Spain, Sweden, Switzerland, Taiwan, and United Kingdom.
Recall number
Product, codes & lots
Z-0631-2019
Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.; Product code: 2D73DP55, Lot Numbers: TS18060249, TS18070244, TS18080021, TS18080344, and TS18090280.
Z-0632-2019
Protexis Neoprene Surgical Glove, Size 6.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.; Product code: 2D73DP60, Lot Numbers: TS18060125, TS18060250, TS18060328, TS18070031, TS18070245, TS18070392, TS18080025, TS18080345, TS18080444, TS18090119, and TS18090281
Z-0633-2019
Protexis Neoprene Surgical Glove, Size 6.5 This powder-free Surgeon s glovessterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.; Product code: 2D73DP65, Lot Numbers: TS18050409, TS18060149, TS18060240, TS18060312, TS18070036, TS18070106, TS18070306, TS18070371, TS18080026, TS18080348, TS18080445, TS18090113, TS18090159, TS18090212, and TS18090282.
Z-0634-2019
Protexis Neoprene Surgical Glove, Size 7.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.; Product code:, 2D73DP70, Lot Numbers: TS18050417, TS18060144, TS18060234, TS18060314, TS18070120, TS18070307, TS18070379, TS18080022, TS18080349, TS18080446, TS18090120, TS18090155, TS18090211, and TS18090288.
Z-0635-2019
Protexis Neoprene Surgical Glove, Size 7.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.; Product code: 2D73DP75, Lot Numbers: TS18060009, TS18060145, TS18060251, TS18060322, TS18070037, TS18070122, TS18070312, TS18070380, TS18080033, TS18080350, TS18090125, TS18090154, TS18090213, and TS18090290.
Z-0636-2019
Protexis Neoprene Surgical Glove, Size 8.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.; Product code: 2D73DP80, Lot Numbers: TS18060134, TS18060230, TS18060323, TS18070039, TS18070313, TS18070372, TS18080027, TS18080351, TS18090164, TS18090218, and TS18090289.
Z-0637-2019
Protexis Neoprene Surgical Glove, Size 8.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.; Product code: 2D73DP85, Lot Numbers: TS18060015, TS18060329, TS18070121, TS18070314, TS18080034, TS18080352, and TS18090219.
Z-0638-2019
Protexis Neoprene Surgical Glove, Size 9.0 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.; Product code: 2D73DP90, Lot Numbers: TS18060016, TS18070126, TS18070315, TS18080353, and TS18090220.
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product code and lot numbers listed in the recall notice to confirm if your gloves are affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 49 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution: US (Nationwide distribution) to states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN,…” 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, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 6.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0637-2019 (October 31, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0637-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.