FDA Medical Device Recalls (openFDA)
SVS LLC: Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.
- Recall number
- Z-2320-2024
- Recalling firm
- SVS LLC
- Product
- Non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.
- Status
- Open, Classified
- Initiated
- 2024-05-13
- Posted
- 2024-07-09
- Terminated
- not on file
- Reason
- Firm received complaints regarding skin irritation when using the gloves, disintegration of the gloves when used with certain cleaning solutions, and mislabeled products (e.g., outer box indicating one size, but inner box indicating another size).
- Root cause
- Under Investigation by firm
- Action
- Consignees were notified via email on 05/13/2024. The consignees are instructed to discontinue using PremierPro PlusTM D506X series exam gloves; Notify end-users of this voluntary recall notification and discontinue use of the products within your healthcare facilities; Remove these products from areas where they may be available including all points of care, supply part locations, and central supply warehouses; Return the products within Table A above to the firm at the firm's expense. All returns of the above-listed products will be replaced by S2S Global with internationally-sourced PremierProTM 506x gloves unless the consignee indicates a different preference; Continue reporting any and all issues that may arise with the use of domestically-sourced PremierPro PlusTM D506X series exam gloves to S2S Global; and " Return the completed Medical Device Recall Return Response Acknowledgement and Receipt Form located in Appendix A below to S2S Global.
- Quantity
- 155,540 inner boxes
- Distribution
- US Nationwide distribution in the states of MI, NE, FL, GA, PA, AR, CO, and NY.
- Lot, serial or model codes
- Item Numbers: size XS - D5061/lot number: AEAM1105/UDI: 00811220035433; size S - D5062/lot number: AEAM1103,AEAM1104,AEAM1105,AEAM1106,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0310,AEAN0311,AEAN0312,AEAN0316,AEAN0317,AEAN0318/ UDI: 00811220035440; size M - D5063/lot number: AEAM1104,AEAM1105,AEAM1112,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0311,AEAN0312,AEAN0316,AEAN0317,AEAN0318,AEAN0319,AEAN0320,AEAN0206/UDI: 00811220035457; size L - D5064/lot number: AEAM1103,AEAM1104,AEAM1106,AEAN0204,AEAN0205,AEAN0206,AEAN0307,AEAN0308,AEAN0309,AEAN0310,AEAN0311,AEAN0312,AEAN0317,AEAN0318,AEAN0319,AEAN0320/UDI: 00811220035464; and size XL D5065/lot number: AEAN0204,AEAN0205,AEAN0206,AEAN0308,AEAN0310,AEAN0311/UDI: 00811220035471
- 510(k) numbers
- ["K220825"]
- PMA numbers
- not on file
- Product code
- LZC
- Firm FEI
- 3007304336
- Firm city
- Charlotte
- Firm state
- NC
- 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