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 deaths or serious injuries are reported, 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

11401–11425 of 13816

SevereFDA (Devices)·Z-1490-2022·2022-08-17
Crome Implantable Cardioverter Defibrillators may deliver reduced shock energy
Medtronic recalls 866 Crome implantable defibrillators due to potential reduced shock energy delivery during high-voltage therapy, affecting devices worldwide. Patients should contact their physician to determine if their device is affected.
Product
Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1487-2022·2022-08-17
Cobalt Implantable Cardioverter Defibrillators May Deliver Reduced Shock Energy
Certain Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during therapy, potentially reducing treatment effectiveness. Medtronic is recalling affected units worldwide.
Product
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1400-2022·2022-08-17
Viral Transport Container Distributed Without FDA Clearance or Guidance Compliance
Haimen Shengbang Laboratory Equipment recalled 100,000 viral transport containers distributed without FDA clearance and outside FDA guidance, affecting facilities in California, Florida, Illinois, New York, and China.
Product
HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1514-2022·2022-08-17
Lithotripsy Generator Recall Due to Mis-Wired Component Affecting System Reliability
Olympus Corporation recalls 2 units of the ShockPulse-SE Lithotripsy Generator due to a mis-wired component that causes improper power supply noise and EMC non-compliance, potentially affecting device reliability and treatment delivery.
Product
ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1516-2022·2022-08-17
Aeos Robotic Digital Microscope software errors affect autofocus and rebalancing
Aesculap is recalling Aeos Robotic Digital Microscopes (versions 2.7 or earlier) due to application errors affecting rebalancing, recovery, and autofocus. Five units were distributed in Arkansas, Indiana, Nebraska, and North Carolina.
Product
Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1513-2022·2022-08-17
Xhibit Telemetry Receiver Model 96280 alarm escalation software defect
Xhibit Telemetry Receiver Model 96280 units fail to escalate critical alarms after approximately 25 days of continuous use, including signal loss, low battery, and SpO2 sensor issues. Caregivers may not be aware of device failures.
Product
Xhibit Telemetry Receiver, Model: 96280
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1507-2022·2022-08-17
Haiou Needle Retractable Safety Syringe recalls due to needle detachment risk
Approximately 7,218,000 Haiou Needle Retractable Safety Syringes are being recalled due to needle detachment and retracting mechanism failures that increase needlestick injury risk. The affected product was distributed in California.
Product
Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-23G25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1506-2022·2022-08-17
HAIOU Retractable Safety Syringes Recalled for Needle Detachment Risk
HAIOU retractable safety syringes are recalled due to reports of needle detachment from the syringe after injection and failure to retract, increasing needle stick injury risk. Approximately 4.05 million units are affected.
Product
HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box. Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-25G25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1511-2022·2022-08-17
GE Healthcare CT, PET, and NM Patient Tables May Drop During Service
GE Healthcare patient tables used in CT, PET, and NM systems can drop during service if technicians remove incorrect screws without appropriate supports, potentially injuring service personnel.
Product
Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1510-2022·2022-08-17
FDA Recalls 3D Systems VSP Scapula Marking Guide Due to Design Defect
Medical Modeling, Inc. is recalling the 3D Systems VSP Reconstruction Scapula Marking Guide (Model VSPR-301) because it was incorrectly designed. The device was distributed internationally, including to Germany.
Product
3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1509-2022·2022-08-17
MetaFix hip stem mislabeled with wrong size and batch information
A Corin MetaFix hip stem (size 7 collarless) was incorrectly labeled as a size 3 collared stem with wrong batch information. The labeling error creates risk during surgical implantation.
Product
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1515-2022·2022-08-17
Roche cobas e801 Analyzer Recall: Software Defect Affects Test Results
Roche is recalling approximately 965 cobas e801 Immunoassay Analyzers nationwide due to a software issue that impacts Pre-Wash test signals and results for six diagnostic assays. No injuries or illnesses have been reported.
Product
cobas e801 Immunoassay Analyzer
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1508-2022·2022-08-17
Cholestech LDX cholesterol test cassettes require bilirubin interference label update
Alere is updating the package insert for Cholestech LDX cholesterol test cassettes to disclose that samples with elevated bilirubin can produce inaccurate triglyceride and HDL results. Approximately 436,990 units are affected.
Product
The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or
Category
Medical Device
Distribution
31 states
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-1481-2022·2022-08-10
Endoscopic Grasper Instruments Recalled Due to Weld Separation Risk
Aesculap Implant Systems is recalling PRESTIGE ATRAUMATIC GRASPER surgical instruments because the weld connecting the handle to the shaft may separate during use.
Product
PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1502-2022·2022-08-10
UroLift System recalled for potential implant deployment failure
Neotract Inc is recalling 18,722 UroLift Systems due to potential improper implant deployment during use. Patients should contact their healthcare provider.
Product
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-1500-2022·2022-08-10
Craftmatic Legacy Bed Base Recalled for Potential Separation Risk
Craftmatic Industries recalls the Legacy Base for Dual Bed Configurations due to a potential for beds to separate or slip away from one another. The defect poses a risk of unintended bed movement.
Product
Legacy Base for Dual Bed Configurations
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1499-2022·2022-08-10
Craftmatic Model 1 Adjustable Bed Base Recalled for Separation Risk
Craftmatic Industries is recalling the Model 1 Base for Dual Bed Configurations due to a potential for the bed bases to separate or slip apart. This defect could cause dual-configured beds to shift unexpectedly.
Product
Craftmatic Model 1 Base for Dual Bed Configurations
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1495-2022·2022-08-10
Pacemaker Programmer Software May Display Overestimated Battery Longevity
St. Jude Medical's Merlin PCS 3650 programmer software may display overestimated predicted battery longevity for certain pacemakers. This could affect clinical decision-making regarding device maintenance and replacement timing.
Product
Merlin PCS 3650 programmer Model 3330 software
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1482-2022·2022-08-10
PRESTIGE RETRACTION GRASPER recalled due to potential weld separation
The FDA is recalling 399 units of the PRESTIGE RETRACTION GRASPER surgical instrument due to risk of weld separation between the handle and shaft. This defect could cause device malfunction during surgical procedures.
Product
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1498-2022·2022-08-10
Atellica CH Iron_2 Diagnostic Device Produces False Microalbumin Results from Reagent Carryover
Siemens Atellica CH Iron_2 in vitro diagnostic devices are being recalled because they produce falsely elevated microalbumin test results when a microalbumin test immediately follows an iron test. No illnesses have been reported.
Product
Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and (lithium heparin) plasma samples.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1442-2022·2022-08-10
NanoSight NS300 Medical Device Recalled for Laser Safety Noncompliance
Malvern Panalytical is recalling 507 NanoSight NS300 units due to noncompliance with Class 1 laser safety requirements. The device may not meet established safety standards for laser-based instruments.
Product
NanoSight NS300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1496-2022·2022-08-10
Merlin 2 PCS MER3400 programmer software recalled by St. Jude Medical
St. Jude Medical recalled Merlin 2 PCS MER3400 programmer software version 1.1.2 revision 1 or earlier in an FDA Class II recall. The recall affects 622 units distributed across the United States and internationally.
Product
Merlin 2 PCS MER37000 programmer Model MER3400 software
Category
Medical Device
Distribution
53 states
HighFDA (Devices)·Z-1484-2022·2022-08-10
E-100 Generator electrosurgical units recalled due to preventative maintenance oversight
Intuitive Surgical is recalling 505 E-100 electrosurgical generators because required preventative maintenance was not performed on units distributed worldwide and in the US.
Product
The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

11401–11425 of 13816