The Recall Desk

Hazard

Unapproved Use recalls

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

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2021-09-08

Of the 6 unapproved use 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 unapproved use 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.

1–6 of 6

  • HighFDA (Devices)·Z-2410-2021·2021-09-08

    COVID-19/Flu Rapid Test Distributed to Non-Certified Laboratories

    COVID-19/Flu rapid diagnostic test was distributed to laboratories not certified under federal clinical standards. The 563,290-unit recall affects nationwide distribution; products were authorized only for CLIA-certified laboratories.

    Product
    Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens Simultaneous qualitative detection and differentiation of nucleocapsid antigen from SARS-CoV-2, influenza A and influenza B directly from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2021·2021-06-30

    Ultrasonic Probe Cover Recalled Due to Lack of FDA Clearance for Body Cavity Use

    Exact Medical Manufacturing is recalling 12,650 ultrasonic probe covers (Item A-AU-0980N) that were marketed for use in body cavities without FDA 510(k) clearance.

    Product
    Probe Cover, 6"x96" poly, tapered end, w 3 bands-Ultrasonic Transducer Cover Item ID: A-AU-0980N
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1907-2021·2021-06-30

    Ultrasonic Probe Covers Recalled for Missing FDA Clearance

    Exact Medical Manufacturing is recalling ultrasonic probe covers due to missing FDA 510(k) clearance for use in natural or surgical body openings. The recall affects 8,800 units distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

    Product
    Probe Cover 6" x 48" regular PE w/ 2 Elastic Bands-Ultrasonic Transducer Cover Bulk Non-sterile Item ID: A-AU-0776NA
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1957-2016·2016-06-22

    Miami Fat Supply Recalls Red Head 2 Fat Harvesting Canisters

    Miami Fat Supply is recalling 443 Red Head 2 Reusable Fat Harvesting Canisters because they were marketed without FDA clearance and are not approved for multiple use.

    Product
    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1697-2015·2015-06-10

    Coreva Recalls ActCel Hemostatic Dressing for Unapproved Marketing Claims

    Coreva Health Science is recalling ActCel Hemostatic Dressing because customer literature and websites promoted unapproved uses for controlling bleeding in body cavities.

    Product
    ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose For Bleeding Control For external topical and temporary use only Sterility of contents guaranteed unless individual envelope is d
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-2014-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining knee implant components because surgeons are using them in unapproved combinations with standard parts.

    Product
    00587806126 Patella MICRO POROUS PAT 26MM X 10MM, Rx, Sterile; 00587806129 Patella MICRO POROUS PAT 29MM X 10MM, Rx, Sterile; 00587806132 Patella MICRO POROUS PAT 32MM X 10MM, Rx, Sterile; 00587806135 Patella MICRO POROUS PAT 35MM X 10MM, Rx, Sterile; Used in total k
    Category
    Medical Device
    Distribution
    Distributed nationwide