The Recall Desk

Hazard

Missing 510k Clearance 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
2021-07-21

Of the 6 missing 510k clearance 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 missing 510k clearance 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-2071-2021·2021-07-21

    Arrow Temporary Pacing Catheter Distributed Without FDA 510K Clearance

    Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit because it was marketed without required FDA 510K clearance. Approximately 15 units were distributed in multiple U.S. states.

    Product
    Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1910-2021·2021-06-30

    Ultrasonic Transducer Covers Lack FDA Clearance for Body Cavity Use

    Exact Medical Manufacturing is recalling 7,920 ultrasonic transducer probe covers distributed across six states and Puerto Rico because they lack required FDA 510(k) clearance for use in body cavities and surgical openings.

    Product
    6" x 96" Elastic Poly Probe Cover, T Tip,Tele Fold, 3 bands - Ultrasonic Transducer Cover Item ID: A-AU- 0853NA
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1912-2021·2021-06-30

    Ultrasound Transducer Probe Covers Recalled for Missing FDA Clearance

    Exact Medical Manufacturing is recalling ultrasound transducer probe covers due to lack of FDA 510(k) clearance for use in natural or surgical body openings. The covers were distributed across six U.S. states and Puerto Rico.

    Product
    6" x 48" Elastic Poly Probe Cover, Tele Fold, sq. end,2 band - Ultrasonic Transducer Cover Item ID: A-AU-10- 058N
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1914-2021·2021-06-30

    Ultrasonic Probe Covers Lack FDA Clearance for Body Use

    Exact Medical Manufacturing recalls ultrasonic transducer probe covers marketed without required FDA 510(k) clearance for use in body openings. Approximately 129,600 units distributed to FL, MT, NY, OH, GA, and Puerto Rico.

    Product
    Probe Cover Elastic Poly 6" x 48"- Ultrasonic Transducer Cover Item ID: E5322N
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1915-2021·2021-06-30

    Transducer Covers Recalled for Missing FDA 510(k) Clearance

    Exact Medical Manufacturing is recalling 100,600 transducer covers distributed across six states because they lack required FDA 510(k) clearance for use in natural or surgical body openings.

    Product
    Transducer Cover 15x147cm, Kit, VIP Film w/ Bands & EMM Gel Item ID: E6359
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1922-2021·2021-06-30

    Ultrasonic Transducer Probe Covers Recalled Due to Missing FDA Clearance

    Exact Medical Manufacturing recalled 36,000 ultrasonic transducer probe covers due to missing FDA 510k premarket notification clearance. The affected units were distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.

    Product
    Probe Cover 6"x48"- Ultrasonic Transducer Cover Item ID: SH29
    Category
    Medical Device
    Distribution
    6 states