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 ARTHROSCOPY PACK

  • 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 Halyard ARTHROSCOPY PACKsee related information
Date Initiated by FirmSeptember 08, 2026
Date PostedNovember 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0358-2027
Recall Event ID 99964
Product Classification General surgery tray - Product Code LRO
ProductHalyard ARTHROSCOPY PACK. Model/Catalog Number: SAMM014-21.
Code Information Model/Catalog Number: SAMM014-21. UDI-DI: 10809160515600. Lot Number: 1698318. Expiration Date: 12/3/2026.
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		Shelf label of kit is mislabeled as "Extremity" instead of "Arthroscopy Pack."
FDA Determined
Cause 2		Process control
ActionAVID Medical notified consignees on about 09/08/2026 via emailed "URGENT: MEDICAL DEVICE FIELD CORRECTION" letter. Consignees were instructed to segregate and quarantine product identified, to add the corrected shelf label to all affected kits in inventory, and if any of the affected units have been further distributed to notify those consignees. Additionally, consignees were requested to complete and return the provided Recall Response Form by GM-OMRA_RECALLS@owens-minor.com. If you have any questions, contact Manager, Regulatory Affairs at 470-280-4277.
Quantity in Commerce17 kits
DistributionUS Nationwide distribution in the state of Texas.
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.
-
-