The Recall Desk
HighFDA (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.

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. 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 sensiti
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Gloves
Hazard
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 →

Related recalls

Same manufacturer · Cardinal Health 200, LLC

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Same hazard · structural defect

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