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

3851–3875 of 39824

CriticalFDA (Devices)·Z-1746-2025·2025-05-28
Endopath Echelon Vascular White Reload surgical stapler device lockout
Ethicon Endo-Surgery is recalling the Endopath Echelon Vascular White Reload surgical stapler due to reports of inadvertent instrument lockout during procedures. The lockout prevents cutting and stapling, potentially requiring conversion to open surgery; one patient death has been reported.
Product
Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1767-2025·2025-05-28
Baxter Novum IQ LVP Infusion System underinfusion risk recall
Baxter Healthcare is recalling the Novum IQ LVP Infusion System because the device may deliver less medication than intended when using standby mode or after being powered off with the set loaded.
Product
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1757-2025·2025-05-28
Bard Blakemore Esophageal-Nasogastric Tube Child Difficult Plug Removal
C.R. Bard is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Child) due to customer complaints that plastic plugs may be difficult or impossible to remove, preventing inflation of the gastric and esophageal balloons.
Product
Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110
Category
Medical Device
Distribution
52 states
SevereFDA (Devices)·Z-1755-2025·2025-05-28
Bard Minnesota Four Lumen Esophagogastric Tamponade Tube Recalled
C.R. Bard Inc is recalling the Bard Minnesota Four Lumen Esophagogastric Tamponade Tube (REF:0092220) because users may be unable to or have difficulty removing plastic plugs needed to inflate the gastric and esophageal balloons.
Product
Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber
Category
Medical Device
Distribution
52 states
SevereFDA (Devices)·Z-1756-2025·2025-05-28
Bard Blakemore Esophageal-Nasogastric Tube difficult balloon inflation
C.R. Bard is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Adult) because users may find it difficult or impossible to remove the plastic plugs needed to inflate the gastric and esophageal balloons.
Product
Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100
Category
Medical Device
Distribution
52 states
SevereFDA (Devices)·Z-1758-2025·2025-05-28
Bard Blakemore Esophageal-Nasogastric Tube Intermediate Balloon Inflation Difficulty
C.R. Bard Inc is recalling Bard Blakemore Esophageal-Nasogastric Tubes (Intermediate, REF 0092300) due to reports that plastic plugs may be difficult or impossible to remove, preventing proper inflation of the gastric and/or esophageal balloons.
Product
Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300
Category
Medical Device
Distribution
52 states
SevereFDA (Devices)·Z-1760-2025·2025-05-28
Centerline Biomedical IOPS Guidewire 2 Coating Delamination Risk
Centerline Biomedical is recalling the IOPS Guidewire 2 (Lot 2404-2005) because the coating may delaminate during use, potentially compromising the guidewire's function during catheter placement procedures.
Product
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-1759-2025·2025-05-28
Bard Single Intragastric Linton Balloon Tube difficult plastic plug removal
C.R. Bard Inc is recalling the Bard Single Intragastric Linton Balloon Tube (REF: 0092740) because users may be unable or find it difficult to remove plastic plugs needed to inflate the gastric and esophageal balloons.
Product
Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-1807-2025·2025-05-28
TRUE 3D VIEWER SYSTEM displays medical images with incorrect orientation
Echopixel's TRUE 3D VIEWER SYSTEM may display imaging data with incorrect orientation (left/right/superior/inferior/anterior/posterior), which could lead to inaccurate measurements during clinical use.
Product
TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D V
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1785-2025·2025-05-28
True 3D Viewer Model EP-00003 Software Orientation Display Issue Recall
Echopixel's True 3D Viewer (Model EP-00003) with certain software versions can display ultrasound image orientation incorrectly, potentially leading to misdiagnosis or incorrect surgical planning.
Product
True 3D Viewer, Model: EP-00003
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1787-2025·2025-05-28
Check-Flo Performer Introducer Medical Device Recall Notice
Cook Incorporated is recalling Check-Flo Performer Introducer devices because some units from affected lots may contain an incorrectly sized introducer sheath.
Product
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1791-2025·2025-05-28
SmartPath to Ingenia Elition X MRI Systems Alignment Error Recall
Philips is recalling SmartPath to Ingenia Elition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. The alignment errors could affect image interpretation.
Product
Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1808-2025·2025-05-28
BD Cathena Safety IV Catheter manufacturing defect hole septum
Becton Dickinson is recalling certain BD Cathena Safety IV Catheter models due to a manufacturing defect that may create a hole in the septum, potentially causing blood leakage during insertion.
Product
BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1812-2025·2025-05-28
PhenoMATRIX bacterial culture plate interpretation software recalled nationwide
Copan WASP is recalling PhenoMATRIX, an AI-powered bacterial culture plate interpretation software, because it lacks required FDA premarket approval, creating potential risk of inaccurate colony counts and morphology data that could affect patient diagnosis.
Product
PhenoMATRIX
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1805-2025·2025-05-28
Philips MR 7700 Medical Device Alignment Error in MobiView Application
Philips is recalling MR 7700 model medical devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product
Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1801-2025·2025-05-28
Philips Ingenia Ambition X MRI Systems Alignment Error in MobiView
Philips is recalling certain Ingenia Ambition X MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product
Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1789-2025·2025-05-28
SmartPath to dStream 3.0T Medical Device Recall for Software Error
Philips is recalling the SmartPath to dStream 3.0T medical device due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. This could affect image interpretation accuracy.
Product
Product Name: SmartPath to dStream for 3.0T; Model Number: 782145
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1788-2025·2025-05-28
Philips SmartPath to dStream 1.5T medical device alignment recall
Philips is recalling certain SmartPath to dStream 1.5T medical imaging devices due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product
Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1793-2025·2025-05-28
Evolution Upgrade 1.5T imaging system alignment error recall
Philips Evolution Upgrade 1.5T medical imaging systems may display alignment errors in cross-reference line functionality when reviewing images via MobiView application.
Product
Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1792-2025·2025-05-28
Philips Upgrade to MR 7700 Medical Device Alignment Error Recall
Philips is recalling the Upgrade to MR 7700 (Model 782130) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application. The misalignment could affect diagnostic accuracy.
Product
Product Name: Upgrade to MR 7700; Model Number: 782130;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1797-2025·2025-05-28
Ingenia 3.0T MRI Systems Recalled for Image Alignment Errors
Philips is recalling certain Ingenia 3.0T MRI systems worldwide due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product
Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1813-2025·2025-05-28
HiResolution Bionic Ear System M Battery Charger Labeling Mismatch Recall
Advanced Bionics, LLC is recalling six units of the HiResolution Bionic Ear System - M Battery Charger (Model CI-5607) due to incorrect product labeling that does not match the intended product.
Product
HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1806-2025·2025-05-28
Smith & Nephew Lag/Compression Screw Kit Undersized Socket Defect
Smith & Nephew is recalling a Lag/Compression Screw Kit (REF: 71642690) because some compression screws have undersized hexagon sockets that render them non-functional and require replacement.
Product
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1799-2025·2025-05-28
Philips Ingenia 1.5T CX MRI System Alignment Error Potential
Philips is recalling Ingenia 1.5T CX MRI systems due to potential alignment errors in the cross reference line functionality when reviewing images with the MobiView application. This could affect image interpretation.
Product
Product Name: Ingenia 1.5T CX; Model Number: 781262;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1794-2025·2025-05-28
Philips Evolution Upgrade 3.0T MRI Cross Reference Line Alignment Error
Philips is recalling Evolution Upgrade 3.0T MRI systems (Models 782117 and 782143) due to potential alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Product
Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;
Category
Medical Device
Distribution
Distributed nationwide

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3851–3875 of 39824