Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

9876–9900 of 40056

HighFDA (Devices)·Z-2037-2023·2023-07-05
Dental Implant Abutments Recalled Due to Lack of FDA Clearance
Implant Direct Sybron is recalling LEGACY SMARTBASE dental abutments distributed without FDA clearance. Performance characteristics have not been adequately established.
Product
LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1971-2023·2023-07-05
Integre Pro Laser Ophthalmoscope Systems: Risk of Unintended Laser Emission
Ellex Medical is recalling certain Integre Pro laser ophthalmoscope systems because scattered laser radiation may unintentionally exit the device and be emitted from the objective lens, potentially exposing users' eyes to unexpected laser energy.
Product
Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2038-2023·2023-07-05
Remel Haemophilus Test Medium Agar Packages Recalled for Performance Failure
Remel is recalling specific lot numbers of Haemophilus Test Medium (Agar) because the test medium may not perform as intended. This diagnostic device is used in laboratory testing nationwide.
Product
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2007-2023·2023-07-05
NaviCare Patient Safety software versions recalled for alert suppression defect
Baxter Healthcare is recalling NaviCare Patient Safety software for Centrella Bed. A software defect may prevent caregiver alerts for patient bed exits and positioning changes.
Product
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2047-2023·2023-07-05
Knee Prosthesis Femoral Segment Recalled Due to Specification Compliance Issue
Waldemar Link is recalling 22 units of the LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left, because device segments may not meet specifications. The company discovered the issue through customer complaints.
Product
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2046-2023·2023-07-05
Knee Prosthesis System Components Recalled for Specification Non-Compliance
Waldemar Link GmbH & Co. KG is recalling 21 units of LINK Endo-Model Modular Knee Prosthesis System Femoral Segment components because they may not meet manufacturing specifications. No injuries have been reported.
Product
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2009-2023·2023-07-05
Orthopedic Baseplate Recall: Manufacturing Defect in Peripheral Holes
Limacorporate is recalling Prima TT Genoid Monoblock Reverse TT Baseplates due to a manufacturing issue that may result in peripheral holes being out of specification.
Product
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2044-2023·2023-07-05
Virtual reality therapy device software malfunction prevents treatment progression
RelieVR VR behavioral therapy device software may malfunction, preventing progression to the next treatment session. No injuries have been reported.
Product
RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-2040-2023·2023-07-05
Diagnostic Test Well Shows Inconsistent Results on Phadia 2500EE
The EliA GliadinDP IgG test well produces higher reported results when used on the Phadia 2500EE instrument compared to the Phadia 250, potentially causing diagnostic inaccuracies. Phadia US Inc is recalling 568 units distributed in California, New Jersey, and Michigan.
Product
EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material Number 12410002) EliA GliadinDP IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2022-2023·2023-07-05
Immunoassay Quality Control Material Recalled for Out-of-Range Values
Randox Laboratories is recalling Immunoassay Premium Control Tri Level quality control kits due to out-of-range values that caused delays in test result reporting. The affected lot was distributed to five states and Puerto Rico.
Product
Immunoassay Premium Control Tri Level-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes Catalog Number: IA2633
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2021-2023·2023-07-05
FDA Recalls Immunoassay Quality Control Material for Out-of-Range Values
Randox Laboratories has recalled a quality control product used in laboratory testing because control values are running outside their target ranges. This can delay when test results are reported.
Product
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-2045-2023·2023-07-05
Mobile Digital X-Ray System Recall: Software Login Issue Affects Units
SEDECAL SA is recalling 1,061 wDR 2.2 Mobile Digital Diagnostic X-Ray Systems due to a software login issue that may prevent users from logging in. The affected units are distributed in the United States and over 70 countries internationally.
Product
wDR 2.2 Mobile Digital Diagnostic X-Ray System
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2041-2023·2023-07-05
Phadia 2500EE diagnostic instrument recalled for measurement inaccuracy
Phadia US Inc is recalling the Phadia 2500EE diagnostic instrument. The device produces higher reported results compared to the baseline Phadia 250 instrument.
Product
Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or plasma (Li-heparin, EDTA) to aid in the diagnosis of celiac disease Material Number 12410002
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-2042-2023·2023-07-05
Philips DigitalDiagnost C90 X-Ray Systems Software Login Issue
Philips is recalling DigitalDiagnost C90 diagnostic imaging systems due to a software login issue that may prevent users from logging in to the device. The recall affects 58 units distributed across the U.S. and internationally.
Product
DigitalDiagnost C90, Model No. 712034 and 712035
Category
Medical Device
Distribution
9 states
CriticalFDA (Devices)·Z-1742-2023·2023-06-28
Medtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
Medtronic implantable cardioverter defibrillators (CRT-D) may deliver reduced or no energy during high-voltage therapy due to manufacturing defect in the feedthrough component. FDA Class I recall affects 182 units.
Product
CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1725-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure
Medtronic's ICD COBALT defibrillators may fail to deliver critical therapy due to a manufacturing defect in a power delivery component. Patients should contact their physician to determine if affected.
Product
ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1769-2023·2023-06-28
Implantable Cardioverter Defibrillators Recalled for Potential High-Voltage Therapy Failure
Medtronic is recalling 664 implantable cardioverter defibrillators due to a rare potential for reduced or no energy output during high-voltage therapy. The defect could prevent critical defibrillation therapy when needed.
Product
CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1755-2023·2023-06-28
Implantable Cardioverter Defibrillators Risk Therapy Failure Due to Feedthrough Defect
Medtronic implantable cardioverter defibrillators may fail to deliver critical therapy due to a feedthrough defect. The defect can cause reduced or absent energy output during high-voltage therapy in 8,602 affected units distributed worldwide.
Product
CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1719-2023·2023-06-28
Medtronic MIRRO MRI Implantable Defibrillator Recall for Potential Therapy Failure Risk
Medtronic's MIRRO MRI implantable cardioverter defibrillators with a specific glassed feedthrough may rarely fail to deliver adequate energy output during high-voltage therapy, affecting approximately 2,831 units distributed worldwide.
Product
ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1738-2023·2023-06-28
Implantable Cardioverter Defibrillators at Risk of Reduced Energy Output During Therapy
Certain implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators may fail to deliver adequate energy during high-voltage therapy due to a specific feedthrough defect. Medtronic is recalling 1,132 affected units.
Product
CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1731-2023·2023-06-28
Medtronic Implantable Cardioverter Defibrillators Recalled for Potential Therapy Failure
Medtronic is recalling 661 CRT-D implantable defibrillators due to a rare manufacturing defect that may reduce or eliminate energy output during therapy delivery. Affected devices may fail to deliver necessary electrical treatment during cardiac emergencies.
Product
CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1728-2023·2023-06-28
Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
Medtronic is recalling certain ICD and CRT-D devices that may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The recall affects 2,018 units distributed nationwide and worldwide.
Product
ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1819-2023·2023-06-28
Implantable defibrillators may fail to deliver high-voltage therapy during treatment
Certain Medtronic ICD and CRT-D devices with a specific feedthrough may fail to deliver energy during high-voltage therapy. This rare defect affects 9,325 units worldwide and could compromise cardiac protection.
Product
ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1777-2023·2023-06-28
Implantable Defibrillators Recalled for Rare Risk of Energy Output Failure
Medtronic implantable defibrillators may deliver reduced or no energy during therapy due to a rare electrical defect. Approximately 1,914 units with a specific feedthrough component are affected and distributed worldwide.
Product
CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1710-2023·2023-06-28
Implantable Cardioverter Defibrillators May Fail to Deliver High-Voltage Therapy
Certain Medtronic implantable cardioverter defibrillators manufactured with a specific feedthrough may produce reduced or no energy output during high-voltage therapy, potentially compromising treatment effectiveness.
Product
ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
Category
Medical Device
Distribution
Distributed nationwide

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9876–9900 of 40056