The Recall Desk

Hazard

Oxygen Barrier Deficiency recalls

3 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2024-04-10

Of the 3 oxygen barrier deficiency recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all oxygen barrier deficiency recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–3 of 3

  • HighFDA (Devices)·Z-1415-2024·2024-04-10

    Exactech Shoulder Implant Components Recalled for Inadequate Oxygen Barrier Packaging

    Exactech Equinoxe shoulder implant components (4,007 units) are recalled because their vacuum-sealed packaging lacks a required oxygen barrier layer, potentially allowing material degradation.

    Product
    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Ext
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1421-2024·2024-04-10

    Exactech Equinoxe Shoulder Arthroplasty Liner Recalled for Nonconforming Packaging

    Exactech recalls 447 units of Equinoxe Constrained Humeral Liner due to nonconforming packaging lacking required oxygen barrier layer (EVOH). Affected units were distributed nationwide and internationally.

    Product
    Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0019-2022·2021-10-13

    OPTETRAK Comprehensive Knee System components recalled for inadequate packaging barrier

    Exactech is recalling approximately 242,397 OPTETRAK Comprehensive Knee System tibial components due to inadequate oxygen barrier in vacuum bag packaging. No injuries have been reported.

    Product
    OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product L
    Category
    Medical Device
    Distribution
    Distributed nationwide