Agency classClass IIOur severity:High FDA (Devices)·Z-2916-2020·Announced 2020-09-09

Cardinal Health Recalls PROTEXIS Latex Micro Surgical Gloves Due to Defects

Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves because a degradation defect may cause holes or tears at the cuffs.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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. The hazard involves a structural defect (holes/tears) in a medical barrier device, which poses a risk of harm if the barrier fails, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Cardinal Health 200, LLC is recalling PROTEXIS Latex Micro Surgical Gloves, Size 7.5. The recall involves 7,119,625 units distributed nationwide in the United States. The 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 may compromise the integrity of the glove during use.

Healthcare facilities and consumers who have these specific gloves should stop using them and contact Cardinal Health 200, LLC for instructions on return or replacement. The recall covers specific lot numbers listed in the official FDA notice.

The recalled product

Product: 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…
Manufacturer: Cardinal Health 200, LLC
Category: Medical Device — Surgical Gloves
Hazard: structural-defect
barrier-failure
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 (20)

Item Code: 2D72NT75X Lot #: TS19060031
TS19060065
TS19060168
TS19060302
TS19080080
TS19080176
TS19080203
TS19080262
TS19090027
TS19090064
TS19090167
TS19090272
TS19100111
TS19100197
TS19100244
TS19100262
TS19110041
TS19110102
TS19110176
TS19110238

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 →

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · structural defect