AVID Medical recall: Halyard LAVH PACK
AVID Medical, Inc. is recalling Halyard LAVH PACK – 40 packs. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on July 10, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Halyard LAVH PACK |
| Brand | AVID Medical |
| Company | AVID Medical, Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 10, 2026 |
| Published by FDA | August 26, 2026 |
| Quantity | 40 packs |
| Recall ID | 99443 |
Recalled products
- Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
- FDA recall number
- Z-2964-2026
- Codes, lots and dates
- UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027
- Quantity
- 40 packs
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99443
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Toano, VA, United States
Why it was recalled
The reason the FDA lists: “The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution in the state of TX.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99443, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other AVID Medical recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 30, 2026 |  AVID Medical recall: Halyard IV START KIT NON-STERILEMedical devices · 288 kits (6 cases) | Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminat… Most serious | FDA Class I |
| Sep 30, 2026 | AVID Medical recall: Halyard IV START KIT NON-STERILEMedical devices · 816 kits (17 cases); 192 kits (4 cases) | Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an op… Serious | FDA Class II |
| Sep 23, 2026 | AVID Medical recall: Halyard IV START KIT NON-STERILE REF: KRIV26-02Medical devices · 288 units | Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators whi… Most serious | FDA Class I |
| Sep 23, 2026 | AVID Medical recall: Haylard and 3 more productsMedical devices · 1640 kits; 80 kits; 240 kits; 340 kits | a sterility problem Most serious | FDA Class I |
| Sep 16, 2026 | AVID Medical recall: Halyard IV Start Kit Non-Sterile REF: KRIV26-02Medical devices · 98 Kits | a sterility problem Serious | FDA Class II |
| Sep 9, 2026 | AVID Medical recall: Halyard medical convenience kits labeled as: 1) ENT and 2 more productsMedical devices · 11763 kits; 16223 kits; 816 kits | a sterility problem Serious | FDA Class II |
| Sep 2, 2026 | AVID Medical recall: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK and 1 more productMedical devices · 45 kits; 63 kits; 78 kits; 120 Kits; 130 KITS | Labeling Deficiency: The medical kit labeling fails to identify that the statlock componen… Serious | FDA Class II |
About this recall
Is AVID Medical Halyard LAVH PACK recalled?
Yes. AVID Medical, Inc. recalled it on July 10, 2026; FDA published it August 26, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.