FDA Medical Device Recalls (openFDA)
Cypress Medical Products LLC: Zee Clear Vinyl Medical Examination Gloves, Powder Free, X-Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3063 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants
- Recall number
- Z-0681-2012
- Recalling firm
- Cypress Medical Products LLC
- Product
- Zee Clear Vinyl Medical Examination Gloves, Powder Free, X-Large, Non-Sterile; 100 gloves per box, 10 boxes per case; Distributed by Zee Medical, Inc., Irvine, CA 92606, Made in China; Zee Part No.: 3063 Single Use, medical exam glove worn on the hand to provide a barrier against potentially infectious materials and other contaminants
- Status
- Terminated
- Initiated
- 2011-11-15
- Posted
- 2012-01-11
- Terminated
- 2012-10-08
- Reason
- The gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage defects.
- Root cause
- Nonconforming Material/Component
- Action
- Cypress Medical telephoned the accounts and then sent Urgent Voluntary Medical Device Recall letters dated November 14, 2011, to all affected customers. The letter informed them that the lot of gloves did not meet certain release specifications and that some of the gloves may not provide an effective barrier to infectious material. Customers were requested to cease distribution of the affected product, quarantine the gloves, and contact Cypress Medical's customer service department at 800-334-3646 for a returned goods authorization, return instruction and credit. The accounts were also requested to notify their customers of the recall, and to complete and return the enclosed reply form. For questions regarding this recall call 815-385-0100.
- Quantity
- 160 cases
- Distribution
- Nationwide Distribution including California, Indiana, New York and Texas
- Lot, serial or model codes
- Zee Part No.: 3063, lot number CZA04-22
- 510(k) numbers
- ["K093264"]
- PMA numbers
- not on file
- Product code
- LYZ
- Firm FEI
- 1451040
- Firm city
- Mchenry
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28