Hazard

Lack Of Fda Clearance recalls

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

What the numbers show

Total: 9
Critical: 0
Severe: 1
Most recent: 2026-07-29

Of the 9 lack of fda 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 1 (11%) 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 lack of fda 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.

1–9 of 9

ModerateFDA (Devices)·Z-2769-2026·2026-07-29
Silent Nite Sleep Appliance Recalled Due to Lack of FDA Clearance
Prismatik Dentalcraft, Inc. is recalling Silent Nite Sleep Appliances because the device does not have FDA clearance.
Product
Brand Name: Silent Nite Product Name: Silent Nite Sleep Appliance Model/Catalog Number: SILNT Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1943-2026·2026-05-06
Mesh Style Tip Protectors recalled lacking FDA clearance
Healthmark Industries Co., Inc. is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) distributed nationwide because the product does not have FDA clearance.
Product
Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1695-2025·2025-05-07
Quantum Informatics VIPER Physiological Monitor Recalled for Lack of FDA Clearance
Spectrum Medical Ltd. is recalling the Quantum Informatics VIPER, a patient monitoring software device, because it was marketed without required FDA clearance. The software is used in operating rooms to provide patient safety information.
Product
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice soluti
Category
Medical Device
Distribution
38 states
HighFDA (Devices)·Z-0268-2025·2024-11-06
Nihon Kohden Adult Ear Clip SpO2 Sensors Recalled for Lack of FDA Clearance
Nihon Kohden America Inc. is recalling 64 Adult Ear Clip SpO2 Sensors (Model 809030007) due to lack of FDA market approval and clearance for U.S. distribution.
Product
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-0324-2023·2022-12-07
CoViPoint COVID Test Kits Distributed Without FDA Approval or Clearance
GS Biomark LLC distributed approximately 639,200 CoViPoint COVID test kits without FDA approval, clearance, or authorization across multiple US states.
Product
CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-1143-2022·2022-06-08
Baxter Peritoneal Dialysis Manifold Sets Recalled for Lack of FDA Clearance
Baxter Healthcare Corporation is recalling 180 units of 5 Prong Manifold Sets used in peritoneal dialysis. These products were distributed without FDA regulatory clearance to facilities across nine US states.
Product
5 Prong Manifold Set (with Luer Connectors)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1144-2022·2022-06-08
Baxter Effluent Sample Bags Recalled for Lack of FDA Clearance
Baxter Healthcare recalled 78 Effluent Sample Bags that were distributed without FDA regulatory clearance. The product was distributed in error across eight states.
Product
Effluent Sample Bag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2175-2021·2021-08-11
Fertility IUI Device Recalled for Missing FDA Marketing Authorization
Tenderneeds Fertility LLC is recalling the Flex IUI Set with LED Lighted Speculum due to distribution without FDA marketing authorization. All units sold worldwide prior to December 9, 2019 are affected.
Product
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1913-2021·2021-06-30
Ultrasonic Transducer Probe Cover Recalled for Lacking FDA Clearance
Exact Medical Manufacturing recalled 5,621 ultrasonic transducer probe covers (Item A-AU-1002N) lacking FDA 510(k) clearance for use in natural or surgical body openings, distributed to Florida, Montana, New York, Ohio, Georgia, and Puerto Rico.
Product
Probe Cover, Lite poly, 6"x48", w two bands- Ultrasonic Transducer Cover Item ID: A-AU-1002N
Category
Medical Device
Distribution
6 states