PROTEXIS Latex Micro Surgical Gloves Size 5 — Class II medical device recall Z-2912-2020
Completed recall by Cardinal Health 200, LLC, reported 2020-09-09, distributed nationwide. A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs
| Recall number | Z-2912-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2020-07-29 |
| Classified | 2020-08-28 |
| Reported by FDA | 2020-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 7,119,625 total |
| Reason classes | specification failure |
| Lot numbers | TS19060338, TS19070077, TS19070176, TS19090164, TS19090248, TS19100272, TS19110080, TS20010146, TS20020202, TS20040092, TS20040247, TS20050050, TS20050051, TS20050261, TS20060112, TS20060113, TS20070125 |
| Model numbers | 2D72NT55X |
Product
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.
Reason for recall
A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2912-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.