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U.S. Department of Health and Human Services

Class 2 Device Recall Halyard MINOR PACK

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 Class 2 Device Recall Halyard MINOR PACKsee related information
Date Initiated by FirmSeptember 08, 2026
Date PostedNovember 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0331-2027
Recall Event ID 99967
Product Classification General surgery tray - Product Code LRO
ProductHalyard MINOR PACK. Model/Catalog Number: VASF105-08.
Code Information Model/Catalog Number: VASF105-08. UDI-DI: 10809160451960. Lot Number: 1659384. Expiration Date: 9/30/2027.
FEI Number 1047429
Recalling Firm/
Manufacturer		 AVID Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information ContactMarlene Jones
+1-470-2804277
Manufacturer Reason
for Recall		Potential for open seals on header bags, compromising sterility.
FDA Determined
Cause 2		Process control
ActionAVID Medical notified consignees on about 09/08/2026 via emailed "URGENT: MEDICAL DEVICE CORRECTION" letter. Consignees were instructed to Segregate, Quarantine, and Inspect all kits identified. If the header bag seal appears to be compromised, discard the entire kit. Consignees were also requested to complete and return the provided Recall Response Form. Distributors were instructed to notify customers if affected kits were further distributed. On 10/06/2026 AVID Medical sent an updated "URGENT: MEDICAL DEVICE CORRECTION" letter to consignees via email. The strategy was updated and consignees were instructed not to use the affected kits and that they should either discard or return them. If returning, they should contact customer service for a Return Goods Authorization. Consignees were again requested to complete and return the provided Recall Response Form. Distributors were again instructed to notify customers if affected kits were further distributed.
Quantity in Commerce108 kits
DistributionU.S Nationwide distributor in the state of Illinois.
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.
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