The Recall Desk

Hazard

Uncleared Medical Device recalls

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

What the numbers show

Total
7
Critical
0
Severe
0
Most recent
2024-09-25

Of the 7 uncleared medical device 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 uncleared medical device 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.

1–7 of 7

  • ModerateFDA (Devices)·Z-3154-2024·2024-09-25

    McKesson 60 mL Syringes Recalled Lacking FDA Clearance

    Cypress Medical Products is recalling McKesson 60 mL syringes that lack FDA clearance. The syringes were inadvertently shipped from a distribution center due to an order processing error and were on quarantine.

    Product
    General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1461-2022·2022-08-03

    Blood Glucose Meter Recalled for Marketing Without FDA Clearance

    Touch US Llc recalled 149 etouchus blood glucose meters (model ETM-G01) because they were marketed without FDA 510(k) clearance or approval. The device was distributed nationwide.

    Product
    etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2325-2021·2021-08-25

    Evexia Luxe DVT Prevention Device Recalled for Marketing Without FDA Clearance

    Ortho8, Inc. is recalling the Evexia Luxe DVT Prevention Device because it was marketed without required FDA clearance. The device is intended to prevent deep vein thrombosis.

    Product
    EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2105-2021·2021-07-28

    Cell Marque Rabbit Monoclonal Antibody Distributed Without FDA Clearance

    Cell Marque recalled 41 kits of a rabbit monoclonal antibody product distributed for in-vitro diagnostic use without required FDA clearance. The product was distributed in 16 US states.

    Product
    Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2067-2021·2021-07-21

    Medical device recall: Lingen SAMPLE Virus Sampling Kit lacks FDA clearance

    Mercedes Medical voluntarily recalled Lingen SAMPLE Virus Sampling Kits due to lack of FDA 510(k) clearance. The recall affects units distributed nationwide and internationally.

    Product
    Lingen SAMPLE Disposable Virus Sampling Kit pack, Item SAM ENI MTM-04, containing 2 tubes and 2 swabs/pack; and SAM ENI MTM04TUBE, containing 1 tube/pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2021·2021-06-30

    Ultrasonic Transducer Probe Cover Recall: Missing FDA 510(k) Clearance

    Exact Medical Manufacturing is recalling 1,600 ultrasonic probe covers distributed without FDA 510(k) clearance for use in body cavities and surgical openings. Users should discontinue use immediately.

    Product
    Probe Cover 6" x 96" regular PE w/ 3 Elastic Bands- Ultrasonic Transducer Cover Item ID: A-AU-0778NA
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1918-2021·2021-06-30

    Hays Ultrasound Kit Recalled for Missing FDA Clearance

    Exact Medical Manufacturing recalls 10,020 units of Hays Ultrasound Kit (H1000SE) due to lack of FDA 510(k) clearance for use in body openings. The recall affects units in FL, MT, NY, OH, GA, and Puerto Rico.

    Product
    Hays Ultrasound kit Item ID: H1000SE
    Category
    Medical Device
    Distribution
    6 states