Hazard

Regulatory Non Compliance recalls

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

What the numbers show

Total: 538
Critical: 0
Severe: 60
Most recent: 2026-10-14

Of the 538 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 60 (11%) 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.

76–100 of 538

ModerateFDA (Devices)·Z-2087-2024·2024-05-29
MEDLINE 5ML Non-Sterile Syringes Recalled for Unapproved Configurations
MEDLINE non-sterile syringes (Model 91859) are being recalled because their sizes and configurations exceed the scope of the manufacturer's FDA 510(k) clearance. No illnesses or injuries have been reported.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L PURPLE NITRO Model/Catalog Number: 91859 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2120-2024·2024-05-29
GMAX SYR 60ML/LS Syringes Recalled for Non-Approved Specifications
Jiangsu Shenli Medical is recalling GMAX SYR 60ML/LS syringes (Model TS2260S-M) because the piston syringe sizes and configurations exceed what was approved by FDA in the company's 510(k) clearance.
Product
Brand Name: GMAX Product Name: SYR 60ML/LS syringe Model/Catalog Number: TS2260S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2118-2024·2024-05-29
FDA Recalls GMAX Syringes Due to Unapproved Configuration
Jiangsu Shenli is recalling GMAX 12ML syringes because the device sizes and configurations exceed what was cleared by FDA. Approximately 303,800 units were distributed nationwide.
Product
Brand Name: GMAX Product Name: SYR 12ML/LS syringe Model/Catalog Number: TS2212S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2047-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Exceeding FDA-Cleared Specifications
Jiangsu Shenli Medical is recalling about 38.8 million Medline SYR 10ML L/L non-sterile syringes (Model 83082) because their sizes and configurations exceed FDA-cleared specifications. Nationwide distribution in CA, FL, GA, IL, TN, and VA.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L Model/Catalog Number: 83082 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2103-2024·2024-05-29
Wolf Medical Syringes Recalled for Uncleared Size and Configuration Variants
Jiangsu Shenli Medical is recalling Wolf Medical 6 mL syringes because certain variants weren't cleared under the 510(k). Approximately 454,400 units distributed nationwide are affected.
Product
Brand Name: Wolf Medical Product Name: 6 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR06L Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2115-2024·2024-05-29
GMAX SYR 35ML Non-Sterile Syringes Recalled for Regulatory Non-Compliance
The FDA is recalling GMAX SYR 35ML/LL non-sterile syringes because the device specifications exceed what the manufacturer had FDA clearance to produce. No illnesses have been reported.
Product
Brand Name: GMAX Product Name: SYR 35ML/LL syringe Model/Catalog Number: TS2235L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·24742·2024-03-28
Forias Pack and Play Mattresses Recalled for Infant Suffocation Hazard
Forias pack and play mattresses sold on Amazon.com from May through August 2023 violate federal crib mattress safety standards and pose a suffocation hazard to infants. The product is missing required warnings and labels.
Product
Forias Pack and Play Mattresses
Category
Consumer Product
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
ModerateFDA (Devices)·Z-1189-2024·2024-03-06
Abbott Vysis Diagnostic Kits Recalled for U.S. Regulatory Non-Compliance
Abbott Molecular recalls five Vysis in-vitro diagnostic kits that were intended for export and shipped to U.S. customers without approval or registration per U.S. specifications.
Product
In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1085-2024·2024-02-21
Stryker Trevo Trak 21 Microcatheter Recalled for Unevaluated Intended Use
Stryker, Inc. is recalling 63 units of the Trevo Trak 21 Microcatheter because the device instructions contain an intended use that has not been evaluated by the FDA.
Product
Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0489-2024·2023-12-13
Vyaire Flexible Patient Circuits 3100A Distributed Without U.S. Approval
Vyaire's Flexible Patient Circuits (29028-004) for the 3100A ventilator were distributed in the U.S., despite being approved only for use outside the U.S. They do not meet U.S. regulatory requirements.
Product
vyaire Flexible Patient Circuit, 3100A, REF 29028-004, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0488-2024·2023-12-13
Vyaire Flexible Patient Circuit 3100A Distributed Without U.S. Approval
Vyaire Medical recalled 188 Flexible Patient Circuit 3100A units distributed in Florida that were approved only for use outside the United States. The circuits were mistakenly distributed in the U.S. market.
Product
vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
Category
Medical Device
Distribution
1 state
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
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
SevereUSDA FSIS·042-2023·2023-09-07
USDA Recalls Frozen Pork Products Imported Without Reinspection
Empacadora Frape, USA LLC is recalling approximately 20,455 pounds of frozen pork chicharron and carnitas that were imported without the required reinspection.
Product
Empacadora Frape, USA LLC, Recalls Pork Products Imported Without Benefit of Import Reinspection
Category
Food
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1587-2023·2023-05-24
Diagnostic Imaging Systems Missing FDA Certification Label
Philips North America is recalling 25 ProxiDiagnost N90 R.1.0 and CombiDiagnost R90 diagnostic imaging systems distributed nationwide because they are missing an FDA-required certification label.
Product
ProxiDiagnost N90 R.1.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1234-2023·2023-03-15
TMJ Reconstruction Prosthesis Recalled for Lacking FDA Regulatory Approval
A patient-fitted temporomandibular (TMJ) reconstruction prosthesis from Stryker Leibinger was recalled after being shipped without FDA regulatory approval. The single device distributed to a customer in Massachusetts has not been evaluated for safety and effectiveness.
Product
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0769-2023·2023-01-04
Orthopedic Compression Screws Distributed Without FDA Pre-Market Clearance
Acumed LLC recalled AcuTwist Acutrak Compression Screws (80,805 units) distributed without FDA pre-market clearance. The devices lack FDA evaluation for safety and effectiveness.
Product
AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0767-2023·2023-01-04
Acutrak Bone Screws and Fusion Devices Recalled for Lack of FDA Pre-Market Clearance
Acumed LLC is recalling Acutrak bone screws and fusion devices distributed without FDA pre-market clearance. Patients should contact their healthcare provider for guidance.
Product
Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm Acutrak¿ 4/5 Bone Screw AM-0035-S 35.0mm Acutrak¿ 4/5 Bone Screw AM-0040-S 40.0mm Acutrak¿ 4/5 Bone Screw AM-0045-S…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1740-2022·2022-09-21
Helix Elite SARS-CoV-2 Reference Standard Recalled for Unregistered UK Distribution
Microbiologics Inc. has recalled Helix Elite Inactivated SARS-CoV-2 reference standards distributed to the United Kingdom because the product was not registered for use in that region.
Product
Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1399-2022·2022-08-17
FDA Recalls 3.95 Million Viral Transport Containers Distributed Without Clearance
The FDA recalled 3.95 million viral transport containers distributed without FDA clearance and in violation of established guidance. The containers were distributed worldwide, including to facilities in California, Florida, Illinois, and New York.
Product
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1451-2022·2022-07-27
LumiraDx SARS-CoV-2 Antibody Quality Control Recalled Due to Unauthorized Modification
LumiraDx is recalling SARS-CoV-2 antibody quality control products because modifications to the test were made outside the scope of FDA-approved authorization. The recall affects 99 units distributed across 13 U.S. states.
Product
LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Category
Medical Device
Distribution
13 states
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-1117-2022·2022-05-25
Portable Oxygen Concentrator Recalled for Lack of FDA Clearance
Caire, Inc. is recalling two CAIRE FreeStyle Comfort portable oxygen concentrators because they were not cleared by the FDA for U.S. distribution. The affected devices were distributed to Puerto Rico.
Product
CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
Category
Medical Device
Distribution
1 state