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.

476–500 of 536

  • ModerateFDA (Devices)·Z-1342-2014·2014-04-16

    LumiQuick H. Pylori Antibody Test Card Recalled for Regulatory Non-Compliance

    LumiQuick Diagnostics Inc. is recalling H. Pylori Antibody Test Cards because they were shipped to locations without required FDA regulatory clearances.

    Product
    H. Pylori Antibody Test Card (Whole Blood) LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1399-2014·2014-04-16

    LumiQuick Propoxyphene Test Strips Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling Propoxyphene Test Strips because they were shipped to US locations without approved applications for PMA, IDE, or 510(k) clearance.

    Product
    Propoxyphene Test Strip; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1354-2014·2014-04-16

    LumiQuick Salmonella Typhi Test Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics is recalling Salmonella typhi IgG/IgM Duo Tests because they were shipped to US locations without required FDA clearance.

    Product
    Salmonella typhi IgG/IgM Duo Test; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1350-2014·2014-04-16

    LumiQuick Malaria Test Cards Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics is recalling Malaria pf Antigen Test Cards because they were shipped to locations without approved FDA applications or clearance.

    Product
    Malaria pf Antigen Test Card; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1372-2014·2014-04-16

    LumiQuick Benzodiazepine Strips Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Benzodiazepine Strips because they were shipped to US locations without required FDA clearances.

    Product
    Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1359-2014·2014-04-16

    LumiQuick Dengue Test Cards Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics is recalling all lots of its Dengue NS1 Ag/IgG/M Ab Duo Test Cards because they were shipped to US locations without the required FDA clearance.

    Product
    Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1339-2014·2014-04-16

    LumiQuick Rickettsia Test Cards Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling Rickettsia IgG/IgM Test Cards because they were shipped to locations without required FDA clearance.

    Product
    Rickettsia IgG/IgM Test Card LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1374-2014·2014-04-16

    LumiQuick Cocaine Strip Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Cocaine Strips shipped to US locations without approved FDA applications.

    Product
    Cocaine Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1410-2014·2014-04-16

    LumiQuick Troponin I Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Troponin I test cards because they were shipped to US locations without required FDA clearance.

    Product
    Troponin I test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1395-2014·2014-04-16

    LumiQuick Buprenorphine Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Buprenorphine Test Cards because they were shipped to locations without required FDA approvals.

    Product
    Buprenorphine Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1269-2014·2014-04-02

    AMS AST Diagnostic Kits Recalled for Marketing Outside 510(k) Requirements

    AMS Diagnostics is recalling 116 AMS AST kits because they were marketed outside FDA 510(k) requirements. The recall covers nationwide distribution.

    Product
    AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0966-2014·2014-02-19

    Neuro Kinetics I-Portal Normative Data Template CD Recalled for Lack of FDA Clearance

    Neuro Kinetics is recalling 148 Normative Data Template CDs for I-Portal devices because the data has not received FDA clearance through the 510(k) process.

    Product
    Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0920-2014·2014-02-12

    Fresenius Bicarbonate Jug Adapter Recalled for Premature Distribution

    Fresenius Medical Care is recalling 703 Bicarbonate Jug Adapters distributed before receiving FDA 510(k) approval.

    Product
    Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0531-2014·2014-01-01

    C.L.R. Medicals Recalls Viscocel Intraocular Fluid Devices for Regulatory Deficiencies

    C.L.R. Medicals International is recalling Viscocel and Viscocel Plus intraocular fluid devices due to FDA inspection findings of quality system deficiencies and lack of Premarket Approval.

    Product
    Viscocel and Viscocel Plus. These products are intraocular fluid devices consisting of non-gaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical tr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0515-2014·2013-12-25

    Instrumentation Laboratory Recalls HemosIL Low Abnormal Control 2 Kits

    Instrumentation Laboratory is recalling 6,504 kits of HemosIL Low Abnormal Control 2 UNASSAYED because the product lacks FDA 510(k) approval.

    Product
    HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0176-2014·2013-11-13

    Pinook Mini Massager Recalled for Failure to Submit Premarket Approval

    Pinook-Usa is recalling 28,994 Pinook Mini Massagers because the company failed to submit a premarket submission and gain approval for the medical device.

    Product
    Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0177-2014·2013-11-13

    Pinook Micro Massager Recalled for Lack of FDA Approval

    Pinook-Usa is recalling 28,994 Pinook Micro Massagers because the company failed to submit a premarket submission and gain FDA approval for the device.

    Product
    Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0144-2014·2013-11-13

    Insight Instruments Recalls MLS Torpedo Mini-Light Ophthalmic Illuminator

    Insight Instruments is recalling MLS Torpedo Mini-Light Ophthalmic illuminators because the product was registered as a Class I device but is actually a Class II device requiring FDA clearance.

    Product
    MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0064-2014·2013-10-30

    DePuy SmartSet GMV Endurance Gentamicin Bone Cement Recalled for Uncleared Indications

    DePuy Orthopaedics is recalling SmartSet GMV Endurance Gentamicin Bone Cement because it is intended for uses not cleared by the FDA.

    Product
    SmartSet¿ Endurance GMV, Gentamicin, REF 3105-040, Medium Viscosity Antibiotic Bone Cement, Sterile. SmartSet GMV Endurance Gentamicin, bone cements are self-curing, radiopaque, polymethyl methacrylate based cements, containing antibiotic, used for securing a metal or polymer
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2160-2013·2013-09-25

    Villa Radiology Juno DRF Mobile X-ray System Recalled for Display Errors

    Villa Radiology Systems LLC is recalling 22 Juno DRF mobile X-ray systems because displayed radiation dose values may be inaccurate by more than 35%.

    Product
    Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2205-2013·2013-09-25

    Camlog Dental Implant Abutments Recalled for Lack of FDA Clearance

    Camlog USA is recalling six dental implant abutments because they were not cleared for sale or use in the United States.

    Product
    C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HS Product Usage: Endosseous dental implant abutment CONELOG Abutments are intended to be used to fabricate prosthetic restorations in conjunction with CONELOG implants to support prostheses in the maxillary and/or mandibul
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2202-2013·2013-09-25

    Sonogage EyeScan A-Scan Biometer Recalled for Lack of FDA Clearance

    Sonogage Inc is recalling 564 EyeScan A-Scan Biometers because the firm lacked FDA registration and 510(k) clearance for the device.

    Product
    Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
    Category
    Medical Device
    Distribution
    Distributed nationwide