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Class IIOngoing

AVID Medical, Inc. recalls 7 products

Recall date · record updated Sep 2, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
AVID Medical, Inc.
Reason
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the states of MS, TX.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99527…

Products (7)

  1. Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK Model/Catalog Number: SAMM064-27

    Codes/lots: Lot Code: Lot Number: 1634391 UDI: 10809160439708Quantity: 45 kitsRecall no. Z-3005-2026Class II

  2. Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

    Codes/lots: Lot Code: Lot Number: 1632948 UDI: 10809160423578Quantity: 63 kitsRecall no. Z-3006-2026Class II

  3. Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

    Codes/lots: Lot Code: Lot Number: 1649979 UDI: 10809160457887Quantity: 78 kitsRecall no. Z-3007-2026Class II

  4. Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

    Codes/lots: Lot Code: Lot Number: 1654575 UDI: 10809160457887Quantity: 78 kitsRecall no. Z-3008-2026Class II

  5. Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

    Codes/lots: Lot Code: Lot Number: 1662335 UDI: 10809160457887Quantity: 120 KitsRecall no. Z-3009-2026Class II

  6. Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

    Codes/lots: Lot Code: Lot Number: 1673233 UDI: 10809160457887Quantity: 130 KITSRecall no. Z-3010-2026Class II

  7. Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03

    Codes/lots: Lot Code: Lot Number: 1649519 UDI: 10809160457887Quantity: 78 kitsRecall no. Z-3011-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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