Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Halyard

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Halyardsee related information
Date Initiated by FirmMay 07, 2026
Date PostedJuly 20, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2763-2026
Recall Event ID 99249
Product Classification Eye tray - Product Code OJK
ProductHalyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit.
Code Information Model/Catalog Number: LVEY27. UDI-DI: 10809160499528. Lot Numbers (Expiration Date): 1680076 (12/31/2026), 1680590 (6/30/2027).
FEI Number 1047429
Recalling Firm/
Manufacturer		 AVID Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information ContactMarlene Jones
757-566-3510
Manufacturer Reason
for Recall		Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
FDA Determined
Cause 2		Process control
ActionAVID Medical notified the single consignee on about 05/07/2026 via email. The consignee was instructed to identify, segregate, and quarantine all impacted products, add the provided warning labels to affected AVID kits to ensure all users are aware of the issue, and discard all impacted components upon opening the Eye Pack. Customers and end users were instructed that if they received affected products from a distributor, to please contact that distributor of sales representatives with questions. Distributors were instructed that if any of the affected kits identified were further distributed, to ensure all end-users are appropriately notified and maintain records of effectiveness. Recipients were requested to complete and return the provided Recall Response Form by 05/22/2026.
Quantity in Commerce260 kits
DistributionUS Nationwide distribution in the state of California.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-