Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects
Cardinal Health is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes and tears at the cuffs.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the defect poses a risk of harm by compromising the barrier protection of surgical gloves, although no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves, Size 9.0. The recall involves 7,119,625 units distributed nationwide in the United States. The affected product is a disposable surgical glove made of natural rubber latex or synthetic rubber intended for operating room personnel to provide barrier protection from contamination.
The recall was initiated because a degradation defect was identified that could lead to holes and donning tears at the folding area around the cuffs. This defect compromises the integrity of the glove, potentially reducing its effectiveness as a barrier against contamination during surgical procedures.
Healthcare facilities and distributors should stop using the affected gloves and contact Cardinal Health for instructions on return or disposal. The specific lot numbers affected include TS19080275, TS19090162, TS19090231, TS20010216, TS20030153, TS20040290, TS20050032, TS20060107, and TS20040344.
The recalled product
- Product
- PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensiti
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Gloves
- Affected units
- 7,119,625
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Item Code: 2D72NT90X Lot #: TS19080275
- TS19090162
- TS19090231
- TS20010216
- TS20030153 Additional Affected Lots of as 10/20/20: TS20040290
- TS20050032
- TS20060107 Additional Affected Lots as of 2/23/21: TS20040344
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Cardinal Health 200, LLC
See all →- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19
- HighCardinal Health Recalls Neurological Procedure Kits Due to Endotoxin Variability
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability
FDA (Devices) · 2026-08-19
- HighCardinal Health Presource Kits Recalled for Endotoxin Variability in Sponges
FDA (Devices) · 2026-08-19
Same hazard · product defect
See all →- ModerateShilpa Medicare Recalls Discolored PEMRYDI RTU Injection Vials
FDA (Drugs) · 2026-08-26
- SevereShilpa Medicare Recalls Discolored Pemetrexed Injection Vials
FDA (Drugs) · 2026-08-26
- ModerateMedline Sterile Water and Saline Bottles Recalled for Leaking Peel-Foil Seals
FDA (Devices) · 2025-05-07
- HighCELL-DYN Ruby hematology analyzer system expiration date validation
FDA (Devices) · 2025-04-30
- HighMedline Procedure Kits with Defective Plastic Syringes Recalled for Safety
FDA (Devices) · 2025-04-02