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.

Which agencies issued them

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.

426–450 of 536

  • ModerateFDA (Devices)·Z-2668-2014·2014-09-24

    Genesis BPS Recalls Pediatric Blood Filter Syringes for Regulatory Non-Compliance

    Genesis BPS, LLC. is recalling 7,272 units of Pedi-Pak Pedi-Syringe Filter 60 mL syringes because the company failed to notify the FDA of material changes.

    Product
    Pedi-Pak Pedi-Syringe Filter 60 mL Becton Dickinson/Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2669-2014·2014-09-24

    Genesis BPS Recalls Pediatric Blood Filter Syringes for Regulatory Non-Compliance

    Genesis BPS, LLC is recalling 4,608 units of Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringes because the company failed to notify the FDA of material changes.

    Product
    Pedi-Pak Pedi-Syringe Filter 35 mL Monoject Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2667-2014·2014-09-24

    Genesis BPS Recalls Pedi-Pak Syringe Filters for Unreported Changes

    Genesis BPS is recalling 7,560 units of Pedi-Pak Pedi-Syringe Filters because the company failed to notify the FDA of material changes to the device.

    Product
    Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2624-2014·2014-09-17

    Integra Container Lids Recalled for Lack of FDA Clearance

    Integra York PA, Inc. is recalling 84 container lids that were distributed without FDA clearance.

    Product
    Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524,
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2181-2014·2014-08-20

    Beevers Recalls Luma Wrap Phototherapy Swaddlers for Regulatory Misclassification

    Beevers Manufacturing is recalling Luma Wrap neonatal phototherapy swaddlers because they were marketed without a required FDA 510(k) clearance.

    Product
    Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1529-2014·2014-08-13

    FDA Recalls Unapproved Vitamin B12 Injection Vials

    Medical Supply Liquidators LLC is recalling Vitamin B12 Hydroxocobalamin Injection vials because the manufacturer is not FDA-registered and the product lacks an approved NDA/ANDA.

    Product
    Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2113-2014·2014-07-30

    Biogenex InSite HER-2 Detection Kit Recalled for Lack of FDA Approval

    Biogenex Laboratories is recalling four InSite HER-2 Detection Kits distributed in Brazil and Ecuador without FDA 510(k) approval.

    Product
    InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2069-2014·2014-07-23

    Axcentria Recalls Calcium Hydroxide Powder Due to Missing 510(k) Approval

    Axcentria Pharmaceuticals is recalling one lot of Calcium Hydroxide Powder because it was distributed without FDA approval and lacks usage instructions.

    Product
    Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further de
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1434-2014·2014-07-23

    Axcentria Recalls Hemo-Stat Solution for Lack of FDA Approval

    Axcentria Pharmaceuticals is recalling Hemo-Stat Solution because it was marketed without an approved NDA/ANDA and lacks an NDC number.

    Product
    Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2042-2014·2014-06-25

    Kodiak Wild Alaska Seafood Recalls Unpermitted Frozen Pacific Halibut Fillets

    Kodiak Wild Alaska Seafood is recalling 42 pounds of frozen Pacific halibut fillets because the firm operated without a required permit or HACCP controls.

    Product
    Pacific halibut, skin-on boneless fillet; vacuum packaged in a clear plastic bag. The wt of the fish is the only labeling included on the product..
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-2041-2014·2014-06-25

    Kodiak Wild Alaska Seafood Recalls Pacific Cod Fillets for Permit Violations

    Kodiak Wild Alaska Seafood is recalling 25 lb vacuum-packed Pacific Cod fillets because the firm distributed frozen seafood without a required operating permit or HACCP controls.

    Product
    Pacific Cod, skinless boneless fillet; vacuum packaged in a clear plastic bag. The wt of the fish is the only labeling included on this product.
    Category
    Food
    Distribution
    2 states
  • LowFDA (Devices)·Z-1785-2014·2014-06-25

    Convatec Recalls Flexi-Seal Fecal Management System for Regulatory and Performance Issues

    Convatec Inc. is recalling the Flexi-Seal Fecal Management System because it lacks FDA 510(k) clearance and its Auto-Valve feature is not performing consistently.

    Product
    Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1944-2014·2014-05-21

    Kaija Ivasi Herring Fillets Recalled for Salt Standard Violation

    Zip International Group LLC is recalling Kaija Ivasi Lightly Salted Herring Fillets in Oil because the product does not meet the required water phase salt standard for processed fish.

    Product
    Kaija Ivasi Lightly Salted Herring Fillets in Oil UPC 3585600709
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1611-2014·2014-05-21

    Mindray DPM 6 Patient Monitor Recalled for Uncleared ST/Arrhythmia Feature

    Mindray DS USA is recalling four DPM 6 patient monitors in Ohio because the included Multi Parameter Module contains a cardiac ST/Arrhythmia analysis feature that is not cleared for marketing.

    Product
    DPM 6 Monitor in use with a Multi Parameter Module (MPM). Patient monitor used for monitoring, displaying, reviewing, storing, and alarming of multiple physiological parameters including ECG, arrhythmia detection, ST segment analysis, heart rate (HR), respiration rate (RESP), te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1545-2014·2014-05-14

    Siemens CLINITEK Status+ Analyzer Recalled for Uncleared Marketing Status

    Siemens Healthcare Diagnostics Inc is recalling CLINITEK Status+ Analyzers with Sample Interference Notes enabled because they were not cleared for US marketing.

    Product
    CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1389-2014·2014-04-16

    LumiQuick PCP Test Cards Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling PCP Test Cards because they were shipped to US locations without required FDA clearance.

    Product
    PCP Test Card; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1405-2014·2014-04-16

    LumiQuick Fentanyl Test Cards Recalled for Unapproved Distribution

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

    Product
    Fentanyl Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1378-2014·2014-04-16

    LumiQuick MDMA/Ecstasy Strip Recalled for Unauthorized Distribution

    LumiQuick Diagnostics is recalling MDMA/Ecstasy test strips because they were shipped to locations without required FDA regulatory clearance.

    Product
    MDMA/Ecstasy Strip; LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1411-2014·2014-04-16

    LumiQuick Cardiac Panel Test Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Cardiac Panel Tests because they were shipped to locations without required FDA approvals.

    Product
    Cardiac Panel Test (Serum); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1355-2014·2014-04-16

    LumiQuick Syphilis Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Syphilis Test Cards (Serum) because they were shipped to US locations without approved PMA, IDE, or 510(k) clearance.

    Product
    Syphilis Test Card (Serum); LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1416-2014·2014-04-16

    LumiQuick CK-MB Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics Inc. is recalling CK-MB Test Cards (Whole Blood) because they were shipped to US locations without required FDA clearance.

    Product
    CK-MB Test Card (Whole Blood); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1402-2014·2014-04-16

    LumiQuick Methylphenidate Test Card Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling Methylphenidate Test Cards because they were shipped to locations without required FDA regulatory clearance.

    Product
    Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1382-2014·2014-04-16

    LumiQuick Methamphetamine Strip Recalled for Unapproved Distribution

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

    Product
    Methamphetamine Strip; LumiQuick, Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1415-2014·2014-04-16

    LumiQuick CK-MB Test Cards Recalled for Unapproved Distribution

    LumiQuick Diagnostics is recalling CK-MB Test Cards shipped to US locations without required FDA clearance.

    Product
    CK-MB Test Card (serum); LumiQuick,. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1362-2014·2014-04-16

    LumiQuick PSA Test Card Recalled for Lack of FDA Clearance

    LumiQuick Diagnostics Inc. is recalling PSA Test Cards (Whole Blood) because they were shipped to US locations without approved FDA applications or clearance.

    Product
    PSA Test Card (Whole Blood); LumiQuick. Santa Clara, CA 95054
    Category
    Medical Device
    Distribution
    5 states