Surgeon'S Gloves
FDA adverse event reports and recall history for surgeon's gloves (product code KGO), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 745
- Deaths
- 2
- Injuries
- 182
- Malfunctions
- 318
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-04-07Open, ClassifiedUnder Investigation by firm
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: GLOVE PACK 7.0 (15PK), Medline SKU # DYNJ63673D
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
- 2023-10-11Open, ClassifiedProcess control
GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290
Some surgical glove sterile pouches were not completely sealed.
- 2023-10-11Open, ClassifiedProcess control
NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290
Some surgical glove sterile pouches were not completely sealed.
- 2020-08-28CompletedUnder Investigation by firm
PROTEXIS Latex Micro Surgical Gloves Size 5.5 - 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 sensitivity or durability depending on need.
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- 2020-08-28CompletedUnder Investigation by firm
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - 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 sensitivity or durability depending on need.
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- 2020-08-28CompletedUnder Investigation by firm
PROTEXIS Latex Micro Surgical Gloves Size 6.5 - 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 sensitivity or durability depending on need.
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- 2020-08-28CompletedUnder Investigation by firm
PROTEXIS Latex Micro Surgical Gloves Size 7.0 - 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 sensitivity or durability depending on need.
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- 2020-08-28CompletedUnder Investigation by firm
PROTEXIS Latex Micro Surgical Gloves Size 7.5 - 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 sensitivity or durability depending on need.
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- 2020-08-28CompletedUnder Investigation by firm
PROTEXIS Latex Micro Surgical Gloves Size 8.0 - 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 sensitivity or durability depending on need.
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
- 2020-08-28CompletedUnder Investigation by firm
PROTEXIS Latex Micro Surgical Gloves Size 8.5 - 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 sensitivity or durability depending on need.
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
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