Hazard

Unapproved Device recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all unapproved device 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.

101–125 of 135

ModerateFDA (Devices)·Z-2501-2025·2025-09-10
Uric acid monitoring kits recalled over missing premarket clearance or approval
A second lot group of Blood Uric Acid Monitoring System kits, model eB-U01, covering all lots made up to June 20, 2022, is recalled for distribution without premarket clearance. 2,580 units are affected.
Product
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2500-2025·2025-09-10
Uric acid meter kits recalled for distribution without premarket clearance
Blood Uric Acid Monitoring System kits, model eB-U01, are recalled because the products were distributed without premarket clearance or approvals. 2,240 units are affected.
Product
Blood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user manual, 10 lancets, and 10 test strips (10-count bottle)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1978-2025·2025-06-25
MiniDock Integrated Nucleic Acid Testing Device Recall
Guangzhou Pluslife Biotech is recalling the MiniDock Integrated Nucleic Acid Testing Device (Model PM001) because it was distributed in the U.S. without required FDA premarket authorization.
Product
Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Pr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0961-2025·2025-01-22
VerifyNow P2Y12 Platelet Reactivity Test distributed without FDA market clearance
Accriva Diagnostics distributed the VerifyNow P2Y12 Platelet Reactivity Test (Lot WL1145) without required FDA clearance. Healthcare professionals could use the unapproved test to guide treatment decisions for P2Y12 inhibitor therapy.
Product
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0267-2025·2024-11-06
Nihon Kohden SpO2 Sensor Recalled Lacking FDA Market Approval
Nihon Kohden America is recalling its Adult/Pediatric Forehead Disposable SpO2 Sensor (Model 809030006) because the device was distributed without FDA market approval or clearance.
Product
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-0091-2025·2024-10-23
Cue Health COVID-19 Test Cartridge Recalled for Unapproved Distribution
Cue Health Inc. is recalling 248,109 COVID-19 test kits (56 lots) that were modified and distributed without FDA approval or authorization. Users should discontinue use and contact the manufacturer.
Product
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2269-2024·2024-07-17
Breast transilluminator recalled due to lack of FDA premarket approval
Silkprousa LLC is recalling the Pink Luminous Breast transilluminator because the device was marketed and distributed without FDA premarket approval. All 2,000 units distributed nationwide are subject to recall.
Product
Pink Luminous Breast, Breast transilluminator
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2108-2024·2024-05-29
FDA recalls GMAX non-sterile syringes sold outside approved specifications
FDA is recalling approximately 1.64 million GMAX non-sterile syringes manufactured by Jiangsu Shenli Medical because they were sold in configurations not approved by the agency.
Product
Brand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2113-2024·2024-05-29
GMAX Non-Sterile Syringes Recalled for Unapproved Sizes and Configurations
GMAX non-sterile syringes in various sizes and configurations have been recalled because they fall outside the FDA 510(k) scope of the manufacturer's clearance. Affected lots were distributed across six U.S. states.
Product
Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2068-2024·2024-05-29
Medline non-sterile syringes recalled for exceeding cleared device specifications
Jiangsu Shenli is recalling Medline 20mL non-sterile syringes (Model 91836, 133,600 units) because certain lot configurations exceed the scope of FDA-cleared specifications. Affected units were distributed across six U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L GREEN Model/Catalog Number: 91836 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1190-2024·2024-03-06
Abbott M1000 Wash Station Shipped Without U.S. Approval or Registration
Abbott Molecular recalled M1000 Wash Station units shipped to U.S. customers without FDA approval or registration. The devices were intended for export only and not approved for U.S. distribution.
Product
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1188-2024·2024-03-06
Abbott in-vitro diagnostic kits shipped without U.S. approval or registration
Abbott Molecular shipped two in-vitro diagnostic FISH probe kits to U.S. customers that were intended for export only and not approved or registered per U.S. specifications. The recall affects 16 kits distributed across eight states.
Product
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2515-2023·2023-09-13
ISee Ortho-K Contact Lenses Recalled Due to Lack of FDA Approval
Paragon Vision Sciences is recalling 83,542 ISee Ortho-K lenses because the manufactured product lacks FDA approval coverage. This is a Class II recall.
Product
ISee Ortho-K Lens
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2516-2023·2023-09-13
Fargo Ortho-K Contact Lens Recall Due to Missing FDA Approval
PARAGON VISION SCIENCES is recalling 18,820 Fargo Ortho-K contact lenses because they were manufactured without required FDA approval. Patients should contact their eye care provider.
Product
Fargo Ortho-K Lens
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1401-2022·2022-08-10
SARS-CoV-2 Rapid Antigen Test Kits Distributed Without FDA Approval
North American Diagnostics is recalling SARS-CoV-2 rapid antigen test kits that were distributed without FDA approval or clearance. Approximately 122,366 units were sold to consumers across multiple US states and internationally.
Product
SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1494-2022·2022-08-10
Unapproved CustMbite Medical Device Recalled Nationwide Due to Missing FDA Clearance
Dental Choice is recalling 708 units of the CustMbite Model CBT-SRS-UL device nationwide because it was marketed and sold without FDA clearance.
Product
CustMbite, Model Number CBT-SRS-UL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1145-2022·2022-06-08
Peritoneal Dialysis Extension Sets Recalled for Missing FDA Clearance
Baxter Healthcare Corporation is recalling 3.65 m peritoneal dialysis extension sets from Lot H19G12025 that were distributed without FDA regulatory clearance. The devices were distributed in error and should not be used.
Product
3,65 m Extension Set with Luer-lock Connector
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1141-2022·2022-06-08
Baxter 15-liter peritoneal dialysis drain bags recalled without FDA clearance
Baxter Healthcare Corporation is recalling 510 units of 15-liter peritoneal dialysis drain bags that were distributed without required FDA regulatory clearance.
Product
15 Liters Drain Bag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1121-2022·2022-06-01
Unclearred VerifyNow P2Y12 Platelet Test Variant Distributed to Healthcare Providers
Accriva Diagnostics distributed an unclearred variant of the VerifyNow P2Y12 platelet test that displays different results than the FDA-cleared device. A correction formula has been provided to healthcare providers.
Product
The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of acti
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1118-2022·2022-06-01
Steris Recalls Ultra Pure Non-Woven Sponges for Unapproved Distribution
Steris Corporation is recalling 103 cases of Ultra Pure Non-Woven Sponges (Lot 202108) distributed nationwide because the product was released without FDA approval. Customers should discontinue use and contact the manufacturer.
Product
Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1091-2022·2022-05-25
ATLAS Stim Headbox Recalled: Unapproved Investigational Device Without Safety Testing
Neuralynx is recalling the ATLAS Stim Headbox, a neurophysiology device distributed without FDA investigational approval or electrical safety clearance.
Product
ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1045-2022·2022-05-18
COVID-19 Antigen Test Kit Distributed Without FDA Authorization or Clearance
The FDA is recalling 17,000 units of Joysbio SARS-CoV-2 Antigen Rapid Test Kits distributed in Alabama and Georgia. The tests were sold without FDA clearance or authorization for marketing in the United States.
Product
Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0861-2022·2022-04-13
Defibrillator devices unapproved for US market recalled by FDA
Remote Diagnostic Technologies recalls Tempus LS defibrillators not approved for US distribution. Two units were distributed in Illinois and Kansas.
Product
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0720-2022·2022-03-09
BUTLER Clear Dip Recalled for Lack of FDA Premarket Clearance
Sunstar Americas is recalling BUTLER Clear Dip nationwide due to lack of FDA premarket clearance. The product was distributed in 22,514 units across multiple lot codes.
Product
BUTLER Clear Dip, 12 bottles/case
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0481-2022·2022-02-09
COVID-19 Test Kits Recalled for Unauthorized FDA Marketing and Sale
Empowered Diagnostics LLC recalled COVID-19 test kits (ImmunoPass, NAB 900-60) sold nationwide without FDA approval. Approximately 2,100 units were distributed without required marketing clearance or authorization.
Product
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Category
Medical Device
Distribution
Distributed nationwide