The Recall Desk

Hazard

Missing Clearance recalls

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

What the numbers show

Total
34
Critical
0
Severe
0
Most recent
2026-03-18

Of the 34 missing 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 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.

1–25 of 34

  • 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-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-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-0534-2026·2025-11-26

    Measles antibody tests recalled for being distributed without premarket clearance

    Quest International is recalling ReQuest Measles IgG enzyme linked immunoassay kits because the in vitro diagnostic was distributed without premarket approval or clearance.

    Product
    Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software Version: N/A Product Description: Measles IgG tests, performed using ELISA (Enzyme-Linked Immunosorbent Assay) method, used to detect the presen
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0500-2026·2025-11-19

    Platelet reactivity tests recalled after an uncleared device was distributed

    Accriva Diagnostics is recalling 125 boxes, 3,125 tests, of VerifyNow PRUTest because a device without premarket clearance was incorrectly packaged and distributed.

    Product
    VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0384-2026·2025-11-05

    Coated and nude regular tampons recalled because product lacks 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Regular and 9 Nude Regular Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0400-2026·2025-11-05

    Initiation 36 coated super tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Initiation 36 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0405-2026·2025-11-05

    Three month all in one bundles recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Initiation 3 Month All in One Bundle because the product lacks 510(k) clearance.

    Product
    Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0406-2026·2025-11-05

    Three month regular flow bundles recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Initiation 3 Month Regular Flow Bundle because the product lacks 510(k) clearance.

    Product
    Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0390-2026·2025-11-05

    Refill tampon packs recalled because the product lacks 510k clearance

    Daye is recalling 3,074 packs of Refill 36 Coated Regular Tampons because the product lacks 510(k) clearance.

    Product
    Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0398-2026·2025-11-05

    Refill three month heavy flow bundles recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Refill 3 Month Heavy Flow Bundle because the product lacks 510(k) clearance.

    Product
    Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0385-2026·2025-11-05

    Coated and nude super tampon packs recalled over missing 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Super and 9 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Super and 9 Nude Super Tampons; Model Number: FG-TMP-REF00090009;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0391-2026·2025-11-05

    Refill coated super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 36 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0394-2026·2025-11-05

    Refill coated and nude super tampons recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 18 Coated Super and 18 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2026·2025-11-05

    Refill regular and super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Refill 18 Coated Regular and 18 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Refill 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-REF18180000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0383-2026·2025-11-05

    Coated regular and super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Regular and 9 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Regular and 9 Coated Super Tampons; Model Number: FG-TMP-REF09090000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0395-2026·2025-11-05

    Refill three month trial tampon boxes recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Refill 3 Month Trial Tampon Box because the product lacks 510(k) clearance.

    Product
    Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2026·2025-11-05

    Coated and nude super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of 9 Coated Super Tampons and 9 Nude Super Tampons because the product lacks 510(k) clearance.

    Product
    9 Coated Super Tampons and 9 Nude Super Tampons; Model Number: FG-TMP-RET00090009;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0401-2026·2025-11-05

    Mixed regular and super tampon packs recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of Initiation 18 Coated Regular and 18 Coated Super Tampons because the product lacks 510(k) clearance.

    Product
    Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0396-2026·2025-11-05

    Refill three month all in one bundles recalled for lacking 510k clearance

    Daye is recalling 3,074 packs of its Refill 3 Month All in One Bundle because the product lacks 510(k) clearance.

    Product
    Refill 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-REFAIO;
    Category
    Medical Device
    Distribution
    Distributed nationwide