The Recall Desk

Hazard

Regulatory Recall 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
2026-04-01

Of the 6 regulatory recall 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 regulatory recall 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

  • ModerateFDA (Devices)·Z-1631-2026·2026-04-01

    BiDop 3 pocket Doppler labeling includes uncleared fetal indication

    Koven Technology is recalling the BiDop 3 Pocket Doppler packaged with a fetal probe because the product labeling includes a fetal indication for use that is not cleared under its 510(k).

    Product
    Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1559-2026·2026-03-18

    Wondfo Streptococcal A self-test recalled because it lacks FDA clearance

    Altruan GmbH is recalling the Wondfo Streptococcal A At-Home Self-Test, used for group A beta-hemolytic streptococcal infection, because the product is not cleared by the FDA.

    Product
    Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1560-2026·2026-03-18

    Clearest Strep-A cassette test recalled because it lacks FDA clearance

    Altruan GmbH is recalling the Clearest Strep-A Cassette Test, used to detect group A streptococci in throat swab samples, because the product is not cleared by the FDA.

    Product
    Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1561-2026·2026-03-18

    Bisaf Strep A self-test recalled because it lacks FDA clearance

    Altruan GmbH is recalling the Bisaf Strep A Self-Test, used to detect group A streptococcal antigens in throat swabs, because the product is not cleared by the FDA.

    Product
    Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1462-2026·2026-03-04

    Edermy PIE PAK units recalled for lacking FDA 510(k) clearance

    Edermy LLC is recalling PIE PAK models P2HC-A, P2HC-S and P2HC because the devices lack 510(k) clearance from the FDA.

    Product
    PIE PAK Models: P2HC-A, P2HC-S, P2HC
    Category
    Medical Device
    Distribution
    Distributed nationwide