The Recall Desk

Hazard

Regulatory Non Compliance recalls

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

What the numbers show

Total
536
Critical
0
Severe
56
Most recent
2026-07-01

Of the 536 regulatory non compliance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 56 (10%) 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 non compliance 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.

126–150 of 536

  • ModerateFDA (Devices)·Z-1362-2021·2021-04-14

    Tenderneeds Fertility Recalls Insemination Kits Lacking Marketing Authorization

    Tenderneeds Fertility LLC is recalling Professional Clinical Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.

    Product
    Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1356-2021·2021-04-14

    Tenderneeds Insemination Device Recalled for Lack of Marketing Authorization

    Tenderneeds Fertility LLC is recalling its At Home Semi-Flex/Rigid Insemination Device because it was distributed without proper marketing authorization.

    Product
    At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1359-2021·2021-04-14

    Tenderneeds Fertility LLC Recalls Deluxe At Home Artificial Insemination Kit

    Tenderneeds Fertility LLC is recalling the Deluxe At Home Artificial Insemination Kit because it was distributed without proper marketing authorization.

    Product
    Deluxe At Home Artificial Insemination Kit (SKU 636391205832)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1357-2021·2021-04-14

    Tenderneeds Fertility Recalls At Home Artificial Intrauterine Insemination Flex Set

    Tenderneeds Fertility LLC is recalling the At Home Artificial Intrauterine Insemination Flex Set because it was distributed without proper marketing authorization.

    Product
    At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1355-2021·2021-04-14

    Tenderneeds Fertility Recalls At Home Artificial Intrauterine Insemination Kits

    Tenderneeds Fertility LLC is recalling At Home Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.

    Product
    At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1364-2021·2021-04-14

    Tenderneeds Fertility Recalls At-Home Insemination Set for Lack of Authorization

    Tenderneeds Fertility LLC is recalling its Professional At Home Artificial Intrauterine Insemination Set because it was distributed without proper marketing authorization.

    Product
    Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1358-2021·2021-04-14

    Tenderneeds Fertility LLC Recalls Deluxe At Home Pro Series Insemination Kit

    Tenderneeds Fertility LLC is recalling the Deluxe At Home Pro Series Insemination Kit because it was distributed without proper marketing authorization.

    Product
    Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1361-2021·2021-04-14

    Tenderneeds Fertility Recalls Professional Artificial Intrauterine Insemination Kit

    Tenderneeds Fertility LLC is recalling its Professional Artificial Intrauterine Insemination Kit because it was distributed without proper marketing authorization.

    Product
    Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1327-2021·2021-04-07

    Stryker Harmonic ACE +7 Shears Recalled for Lack of Regulatory Clearance

    Stryker is recalling 102 units of Harmonic ACE +7 Shears because they were distributed without receiving regulatory clearance.

    Product
    Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0510-2021·2020-12-09

    VEO Diagnostics Recalls ACCEL ELISA COVID-19 Antibody Test Kits

    VEO Diagnostics is recalling 15 ACCEL ELISA COVID-19 antibody test kits because the FDA removed their Emergency Use Authorization. Users should stop using the kits.

    Product
    ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2 Catalog AE301U Kit lots: PXCOV073020, PXCOV081220 Expiration dates: January 18, 2021 and January 26, 2021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0509-2021·2020-12-09

    B. Braun Introcan Safety IV Catheters Recalled for Missing 510(k) Clearance

    Janus Trade Group is recalling B. Braun Introcan Safety IV Catheters distributed in the US without required FDA 510(k) clearance.

    Product
    B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0440-2021·2020-11-25

    Inova Lasers Recalls Class IV New Era Medical Laser Devices

    Inova Lasers LLC is recalling eight Class IV New Era medical laser devices because they failed to comply with Electronic Product Radiation Control regulations.

    Product
    Class IV New Era medical laser device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0470-2021·2020-11-25

    Micro-Tech Elastic Traction Device Recalled for Regulatory Classification Issues

    Micro-Tech USA is recalling Elastic Traction Devices because they are not appropriately classified as Class I and require 510(k) clearance.

    Product
    Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0321-2021·2020-11-11

    Primus Ultra2 Resolution Variants System Recalled for Lack of FDA Clearance

    Primus Corporation is recalling 97 Ultra2 Resolution Variants Systems because the devices did not receive FDA pre-market approval or clearance.

    Product
    Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0094-2021·2020-10-21

    Genicon Aquas PowerFlow Tube Set Recalled for Lack of FDA Clearance

    Genicon, Inc. is recalling 10,808 units of the Aquas PowerFlow Tube Set because the device design did not receive proper premarket clearance from the FDA.

    Product
    Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3017-2020·2020-10-07

    Olympus BF-Q180 Bronchovideoscope Recalled for Infection Risk and Regulatory Issues

    Olympus is recalling BF-Q180 bronchovideoscopes because they lack 510(k) clearance and are associated with a higher rate of patient infections.

    Product
    Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olympus BF Type Q180 (BF-Q180) All serial numbers - Product Usage: designed to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V561000·2020-09-16

    Volkswagen Recalls 23 Internal Use Vehicles for Regulatory Compliance Issues

    Volkswagen is recalling 23 internal use vehicles, including Golf and Passat models, because they may not meet federal safety standards. Owners will be offered a repurchase.

    Product
    VOLKSWAGEN — VOLKSWAGEN GOLF ALLTRACK, EGOLF, PASSAT, GOLF R
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2872-2020·2020-09-09

    GE Healthcare Recalls OEC 9800 and 9900 C-Arms for Dose Display Issues

    GE Healthcare is recalling 221 OEC 9800 and 9900 C-Arms because field service engineers changed the dose display to DAP, violating FDA regulations requiring AKR/CAK.

    Product
    The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, crit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2711-2020·2020-08-05

    TTDEYE Flower Grey Colored Contact Lenses Recalled for Lack of FDA Clearance

    Chengdu Ai Qin E-commerce Co., Ltd is recalling TTDEYE Flower Grey colored contact lenses because they were distributed without FDA clearance.

    Product
    TTDEYE (brand) Flower Grey, B16112231 - Product Usage: Colored contact lenses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2176-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2178-2020·2020-06-10

    FDA Recalls Sterile Custom Surgical Packs Due to Unregistered Facility

    American Contract Systems is recalling 2,868 sterile custom surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2172-2020·2020-06-10

    FDA Recalls Sterile Surgical Packs from Unregistered Facility

    American Contract Systems is recalling sterile custom surgical packs because they were manufactured in a facility not registered by the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2173-2020·2020-06-10

    FDA Recalls Sterile Surgical Packs from Unregistered Facility

    American Contract Systems is recalling 2,868 sterile surgical packs because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2166-2020·2020-06-10

    FDA Recalls Sterile Surgical Kits from Unregistered Facility

    American Contract Systems is recalling 2,868 sterile surgical kits because they were manufactured in a facility not registered with the FDA.

    Product
    Sterile Custom Packs to be used in surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide