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

10351–10375 of 40095

HighFDA (Devices)·Z-1413-2023·2023-04-26
INFINITY Multi-Axial Spinal Screws Recalled for Titanium Material Defect
Medtronic is recalling INFINITY Multi-Axial Spinal Screws due to incorrect titanium material used in manufacturing, which reduces the gripping strength of the screw head. The affected screws are used for spinal fusion and stabilization.
Product
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1400-2023·2023-04-26
FDA Recalls MectaLIF ANTERIOR Spinal Fusion Device Due to Screw Breakage Risk
Medacta Usa Inc is recalling the MectaLIF ANTERIOR Lag Plate Flush H10 interbody fusion device due to a potential risk of screw breakage in the anti-backout plate. No injuries have been reported.
Product
MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1396-2023·2023-04-26
VITROS COVID-19 Antibody Test Calibrators Recalled for Incorrect Calibrator Levels
Ortho-Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total N Antibody Calibrators used in COVID-19 testing due to incorrect calibrator levels in Assay Data Disks, which can delay patient test results.
Product
VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV): DRVs 6213 through 6218 supporting VITROS Calibrators. Product Code: 6199976
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1406-2023·2023-04-26
Avanos Ballard Oral Care Swabs recalled for incorrect expiration date labeling
Avanos Medical is recalling Ballard Oral Care Swabs (codes 12241, 12243, 12251) due to incorrect expiration date labeling. The recall affects 5,475 cases distributed worldwide.
Product
Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1408-2023·2023-04-26
Medtronic SenSight Extension Tunneler Kit: manufacturing defect prevents dual-extension passage
Medtronic recalled approximately 1414 SenSight Extension Tunneler Kits due to a manufacturing defect where dual carriers were machined on only one side, preventing use for passing two extensions simultaneously.
Product
Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1398-2023·2023-04-26
Pressure Therapy System Recalled for Unauthorized Deep Vein Thrombosis Prevention Claim
Compass Health Brands is recalling the REX Pressure Therapy System because the user manual incorrectly claims the device can prevent deep vein thrombosis, an indication for which the device was not FDA-cleared.
Product
REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1391-2023·2023-04-26
KLS E-Coupling Adapter Recalled for Incorrect Product Identifier Code
Pro-Dex Inc is recalling 199 KLS E-Coupling Adapter devices due to incorrect Unique Device Identifier (UDI) and GTIN codes. The devices were distributed nationwide.
Product
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1313-2023·2023-04-19
Ivenix Large Volume Infusion Pump Recalled Due to Fluid Ingress Risk
Fresenius Kabi is recalling the Ivenix Infusion System Large Volume Pump (Model LVP-0004) because fluid ingress can damage the device, causing loss of electrical function and preventing or halting infusion.
Product
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1368-2023·2023-04-19
Inflatable Penile Prosthesis Recalled for Risk of Premature Pump Failure
Coloplast is recalling Titan Touch inflatable penile prostheses with reduced pump wall thickness, which could cause premature failure during use. The defect affects 8 units distributed across the US and multiple European countries.
Product
Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1378-2023·2023-04-19
BioPlex 2200 Anti-CCP Reagent Kit recalled due to reduced test specificity
Bio-Rad is recalling BioPlex 2200 Anti-CCP reagent kits due to reduced specificity that may cause false positive results. Four customer complaints documented discrepant results during validation testing.
Product
BioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1375-2023·2023-04-19
Titan inflatable penile prosthesis recalled due to premature pump failure risk
Coloplast is recalling the Titan 0-Deg inflatable penile prosthesis due to decreased pump wall thickness that may cause premature device failure. The recall affects 23 units distributed worldwide.
Product
Titan 0-Deg Scrotal 22 Cm, Catalog Number ES89222400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1388-2023·2023-04-19
Chromic Gut Absorbable Sutures Recalled for Sterilization Failure Risk
Covidien, LP is recalling chromic gut absorbable sutures due to sterilization failure that may leave product unsterile, creating risk of infection or vision loss in eye surgery.
Product
Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1352-2023·2023-04-19
Flex-Neck Catheter Repair Kit design test product inadvertently distributed to patients
Merit Medical Systems inadvertently distributed 17 Flex-Neck Catheter External Repair Kits intended for design verification testing to customers in Maryland, Michigan, Ohio, and Texas.
Product
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1390-2023·2023-04-19
Unsterile Plain Gut Absorbable Sutures Recalled Due to Sterilization Defect
Covidien recalled 3,228 units of Plain Gut Absorbable Sutures due to a sterilization defect. Unsterile sutures may cause infection or vision loss in eye surgery.
Product
Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1379-2023·2023-04-19
Swan-Ganz Thermodilution Catheter May Bend and Cause Monitor Error
Edwards Lifesciences is recalling Swan-Ganz CCOmbo V thermodilution catheters because the distal end may bend beyond its intended curvature, potentially causing the patient monitoring device to display an error message.
Product
Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
Category
Medical Device
Distribution
50 states
HighFDA (Devices)·Z-1369-2023·2023-04-19
Inflatable Penile Prosthesis Recalled for Premature Pump Failure Risk
Coloplast is recalling Titan Touch Scro Zero Ang 16cm prostheses (Lot 8840677) due to decreased wall thickness that may cause premature pump failure. Affected devices were distributed worldwide, including throughout the US.
Product
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1355-2023·2023-04-19
Medical X-ray Systems Recalled for Electrical Fire Hazard
Philips CombiDiagnost R90 X-ray systems (Model Numbers 709030 and 709031) may experience electrical fire in the main cabinet if exposed to overvoltage or power surge.
Product
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1377-2023·2023-04-19
BioPlex 2200 Anti-CCP Reagent Pack Recalled for Reduced Diagnostic Specificity
Bio-Rad is recalling BioPlex 2200 Anti-CCP Reagent Pack, Lot 301481, because the test's specificity is lower than claimed, which may increase false positive results. The diagnostic kit was distributed worldwide including the US, Canada, and several European countries.
Product
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1372-2023·2023-04-19
Titan Inflatable Penile Prosthesis Pump Failure Risk Recall
Coloplast is recalling the Titan 0-Deg Infrapubic 20 Cm inflatable penile prosthesis due to reduced wall thickness in the pump that could cause premature failure. No injuries have been reported.
Product
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1356-2023·2023-04-19
X-ray System Models 706100 and 706110 Electrical Fire Risk from Power Surge
Philips ProxiDiagnost R90 X-ray systems may experience electrical fires if exposed to overvoltage or power surges. The recalled systems affect 243 units distributed nationwide and globally.
Product
ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1360-2023·2023-04-19
Inflatable Prosthesis Pump Assembly Recalled for Premature Failure Risk
Coloplast is recalling 9 Titan Pump Assemblies for inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure during normal use.
Product
Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1376-2023·2023-04-19
Digital VIPR Oxygen Delivery Systems Recalled for Gauge Malfunction
Western/Scott Fetzer is recalling 24,287 Digital VIPR oxygen delivery systems for a gauge malfunction that may display incorrect pressure readings. This could allow oxygen tanks to deplete without warning, potentially leaving users without oxygen flow.
Product
Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxygen Ready to Use Digital VIPR System (with E-size cylinder) MNDR-600, Western Oxytote DTE Digital VIPR (head only) MNDS-602, Western Oxytote DTE Digital VIPR System (with D-size
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1350-2023·2023-04-19
First Response Easy Read App unable to reliably read pregnancy test results
Church & Dwight's Easy Read App for pregnancy test sticks may fail to display test results or misread them, leading to false positive or false negative results. The app was marketed without required FDA clearance.
Product
Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1365-2023·2023-04-19
Inflatable Penile Prosthesis Recalled for Potential Pump Failure Risk
Coloplast is recalling certain Titan NB Infra Zero Ang 16cm inflatable penile prostheses due to thinner-than-standard pump wall thickness that could lead to premature pump failure.
Product
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1386-2023·2023-04-19
Stryker MAKO RESTORIS tibial baseplate trial recalled for incorrect size marking
Stryker is recalling 102 units of MAKO RESTORIS MultiCompartmental Knee tibial baseplate trials with incorrect size laser markings. Wrong markings could lead to selection of incorrect implant sizes during partial knee replacement surgery.
Product
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Category
Medical Device
Distribution
0 states

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10351–10375 of 40095