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

3451–3475 of 27346

HighFDA (Devices)·Z-0900-2025·2025-01-22
GE Healthcare nuclear medicine imaging systems recalled for detector fall risk
GE Healthcare is recalling 30 units of certain nuclear medicine imaging systems distributed worldwide. If transported without proper detector support, the systems risk detector mounting failure and life-threatening injury.
Product
GE Healthcare Varicam Millennium VG Discovery VH, Model/Catalog Numbers: 1) ASM000085; 2) ASM001092; 3) SYS000001; System, Tomography, Computed, Emission
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0904-2025·2025-01-22
Medtronic NanoCross Elite PTA Catheter Recall Due to Balloon Deflation
Medtronic's NanoCross Elite PTA catheters in certain lots may not deflate properly during use. The FDA is recalling 5,189 units due to potential in-vivo balloon deflation issues.
Product
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0846-2025·2025-01-22
Stryker Blueprint Glenoid Pin Guide May Disassemble During Shoulder Surgery
The metal tube of the Stryker Blueprint Glenoid Pin Guide may disassemble from the plastic handle. This can prevent the guidance system from detecting the device, potentially prolonging surgery or requiring a switch to conventional surgical methods.
Product
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0934-2025·2025-01-22
ECONO STERILE Dental Cement Spatula Kits Recalled for Packaging Issues
Sklar Instruments is recalling ECONO STERILE dental cement spatulas (Model 96-2245M) due to packaging defects that may compromise the sterile barrier. The product was distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0860-2025·2025-01-22
Intuitive Surgical Tenaculum Forceps Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling 11,162 units of 8MM Tenaculum Forceps (Model 470207) due to increased complaints of frayed or broken grip cables on reusable surgical instruments. Users should discontinue use immediately.
Product
8MM,TENACULUM FORCEPS,IS4000¿ REF 470207
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0911-2025·2025-01-22
Cardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health Presource surgical kits and dental packs are recalled due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 512,786 units were distributed worldwide.
Product
Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0910-2025·2025-01-22
Cardinal Health Presource Aneurysm Packs recalled for potential endotoxin contamination
Cardinal Health Presource surgical kits used in aneurysm procedures may contain endotoxin contamination in non-sterile surgical strips and patties. Approximately 512,786 units distributed worldwide; no illnesses reported.
Product
Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM5; 4 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM6; 5 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0925-2025·2025-01-22
ECONO STERILE ear cleaning kits recalled for packaging sterile barrier issues
Sklar Instruments is recalling ECONO STERILE medical procedure kits for ear cleaning due to packaging issues that may result in a breach of the sterile barrier. The kits have been distributed nationwide.
Product
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0873-2025·2025-01-22
Intuitive Surgical 8mm Cadiere Forceps Recalled for Frayed Grip Cables
Intuitive Surgical is recalling 56,580 units of the 8mm Cadiere Forceps (Model 471049) due to increased complaints of frayed or broken grip cables on the reusable surgical instrument.
Product
8MM,CADIERE FORCEPS,IS4000 REF 471049
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0853-2025·2025-01-22
Surgical Forceps Recalled Due to Frayed or Broken Grip Cables
Intuitive Surgical is recalling 8,578 units of Cadiere Forceps surgical instruments due to reports of frayed or broken grip cables. These reusable instruments were distributed throughout the United States and internationally.
Product
8MM,CADIERE FORCEPS,IS4000 ¿ REF 470049
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0863-2025·2025-01-22
8MM Dual Blade Retractors recalled for frayed or broken grip cables
Intuitive Surgical is recalling 8MM Dual Blade Retractors due to increased complaints of frayed or broken grip cables. This defect affects 783 reusable surgical instruments distributed in the U.S. and internationally.
Product
8MM,DUAL BLADE RETRACTOR,IS4000¿ REF 470249
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0858-2025·2025-01-22
Intuitive Surgical Recalls 8MM Mega Needle Driver for Frayed or Broken Grip Cables
Intuitive Surgical is recalling 38,438 units of the 8MM Mega Needle Driver surgical instruments due to complaints of frayed or broken grip cables.
Product
8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0917-2025·2025-01-22
Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Endotoxins could pose a risk if contaminated components are used in sterile surgical procedures.
Product
Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH3; 5) KIT,H N FREE FLAP , Catalog Numb
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0888-2025·2025-01-22
GE Healthcare Nuclear Medicine Systems Recalled for Potential Detector Fall Risk
GE Healthcare nuclear medicine imaging systems may have improper detector support following transport or relocation, potentially causing detector fall and life-threatening injury. The recall affects 36 systems distributed worldwide.
Product
GE Healthcare Infinia I, Model/Catalog Numbers: 1) 5178728, 2) H3000WE, 3) H3000WM, 4) H3000YG; System, Tomography, Computed, Emission
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0930-2025·2025-01-22
Medical procedure kit recall due to sterile barrier packaging breach risk
Sklar Instruments is recalling ECONO STERILE nasal procedure kits due to packaging issues that may compromise sterility. The recall affects 175 units distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0961-2025·2025-01-22
VerifyNow P2Y12 Platelet Reactivity Test distributed without FDA market clearance
Accriva Diagnostics distributed the VerifyNow P2Y12 Platelet Reactivity Test (Lot WL1145) without required FDA clearance. Healthcare professionals could use the unapproved test to guide treatment decisions for P2Y12 inhibitor therapy.
Product
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0891-2025·2025-01-22
GE Healthcare Nuclear Medicine Systems Recalled for Detector Fall Risk
GE Healthcare is recalling 859 units of nuclear medicine imaging systems that may have been transported improperly, risking detector failure and potential life-threatening injury from detector falls.
Product
GE Healthcare Discovery NM/CT 670, Model/Catalog Numbers: 1) 5376204-70-54-2, 2) H2401BC, 3) H2401CE, 4) H2401CG, 5) H3100AG, 6) H3100JW, 7) H3100NC; System, Tomography, Computed, Emission
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0918-2025·2025-01-22
Portrait Core Services Software Loss of Patient Monitoring After 425 Days
A software issue in GE's Portrait Core Services medical device software causes loss of patient monitoring capability in the Portrait Central Viewer Application after 425 days of continuous operation.
Product
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facility infrastructure and clinical information systems, Model CSSXB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0945-2025·2025-01-22
Gynecological Procedure Kits Recalled for Potential Sterile Barrier Packaging Defects
Sklar Instruments is recalling ECONO STERILE gynecological procedure kits due to packaging issues that may compromise the sterile barrier. The affected kits may no longer maintain their sterile condition.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0838-2025·2025-01-22
NOA Medical Industries Hospital Bed Side Rails Recalled for Defective Engagement Button
NOA Medical Industries is recalling 34 hospital bed side rails (Model 1055050GRY-BOX) because the red button used to engage the rails can break or become stuck, making it difficult to engage the safety rails.
Product
NOA Medical Industries Behavioral Health Hospital bed side rails, Product number 1055050GRY-BOX
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0952-2025·2025-01-22
Orthopedic Surgery Kits Recalled for Potential Sterile Barrier Packaging Defects
Sklar Instruments is recalling ECONO STERILE LEMPERT BONE RONG orthopedic surgery kits due to packaging defects that may compromise sterility. The affected kits (Model 96-4780A, Lot HSI) were distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0795-2025·2025-01-15
Oxygen Concentrator May Catch Fire or Melt During Use
The JMC5A Ni/TruAire-5 Oxygen Concentrator (Model O2C5L) is being recalled. The device may catch fire or melt during use, creating a risk of serious injury from fire and burns.
Product
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-0711-2025·2025-01-15
VasoView HemoPro 2 Endoscopic Vessel Harvesting System Class I Recall
FDA recalls VasoView HemoPro 2 endoscopic vessel harvesting systems due to risk of heater wire detachment and silicone peeling from the harvesting tool jaws, which could affect device function.
Product
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0763-2025·2025-01-15
Large Volume Pump model LVP-0004 recalled for potential pneumatic valve failure
Fresenius Kabi is recalling 1,520 Ivenix infusion pumps (model LVP-0004) due to potential pneumatic valve failure that may stop active infusions or prevent pump operation. Affected units were distributed to healthcare facilities in six U.S. states.
Product
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-0712-2025·2025-01-15
Vasoview Hemopro 2 Vessel Harvesting System Recalled for Heater Wire and Silicone Defects
Maquet Cardiovascular is recalling the Vasoview Hemopro 2 Vessel Harvesting System due to potential heater wire and silicone defects. These could affect device function during minimally invasive surgery.
Product
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Category
Medical Device
Distribution
Distributed nationwide

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3451–3475 of 27346