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

4076–4100 of 13449

HighFDA (Devices)·Z-0893-2025·2025-01-22
GE Healthcare Nuclear Medicine Systems Detector Fall Risk
GE Healthcare has recalled certain nuclear medicine systems that could have detectors fall during improper transport, risking life-threatening injury. The recall affects 283 units worldwide.
Product
GE Healthcare Discovery NM/CT 670 PRO, Model/Catalog Numbers: 1) 5376204-70-54-2; 2) H2401AK; 3) H2402AC; 4) H3100AH; 5) H3100XB; System, Tomography, Computed, Emission
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0953-2025·2025-01-22
ECONO STERILE Orthopedic Probes Recalled for Sterile Barrier Breach Risk
Sklar Instruments recalls 2,500 ECONO STERILE orthopedic probe kits due to packaging issues that may breach the sterile barrier. No illnesses or injuries have been reported.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0852-2025·2025-01-22
Intuitive Surgical DeBakey Forceps Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling 1,739 8MM DeBakey Forceps (Model 470036) used in surgical procedures due to increased reports of frayed or broken grip cables. Cable failure could impair instrument function during surgery.
Product
8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0896-2025·2025-01-22
GE Healthcare Nuclear Medicine Systems Recalled Due to Detector Fall Risk
GE Healthcare recalls certain nuclear medicine systems that could have been transported without proper detector support, risking detector falls and life-threatening injury.
Product
GE Healthcare Optima NM/CT 640, Model/Catalog Numbers: 1) H3100JZ; 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-0895-2025·2025-01-22
GE Healthcare Discovery NM/CT 670 Systems Risk of Detector Fall During Transport
GE Healthcare's Discovery NM/CT 670 nuclear medicine imaging systems may have detectors that fall if not properly supported during transport or relocation, posing risk of life-threatening injury.
Product
GE Healthcare Discovery NM/CT 670 CZT, Model/Catalog Numbers: 1) H3906AB; System, Tomography, Computed, Emission
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0936-2025·2025-01-22
ECONO STERILE Medical Procedure Kits Recalled for Sterile Barrier Compromise
Sklar Instruments recalls ECONO STERILE medical procedure kits (300 units nationwide) due to packaging issues that may compromise sterile barrier integrity.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general purpose clips
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0854-2025·2025-01-22
Prograsp Surgical Forceps Recalled Due to Frayed Grip Cables
Intuitive Surgical is recalling 2,852 units of 8MM Prograsp Forceps due to complaints of frayed or broken grip cables. These reusable surgical instruments may lose grip control during use.
Product
8MM,PROGRASP FORCEPS,IS4000 ¿ REF 470093
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0835-2025·2025-01-22
Alcon Monarch III D Delivery Cartridge Recalled for Molding Defect Risk
Alcon is recalling 41,718 units of its Monarch III D Delivery Cartridge due to a molding defect that could scratch the intraocular lens during cataract surgery.
Product
Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/A
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-0871-2025·2025-01-22
Intuitive Surgical 8MM Force Bipolar Instruments Recalled for Frayed Grip Cables
Intuitive Surgical, Inc. is recalling 8MM Force Bipolar surgical instruments due to increased complaints of frayed or broken grip cables on the reusable instruments.
Product
8MM,FORCE BIPOLAR,IS4000 REF 470405
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0855-2025·2025-01-22
Intuitive Surgical Recalls 8MM Micro Bipolar Forceps Due to Frayed Grip Cables
Intuitive Surgical is recalling 178 units of its 8MM Micro Bipolar Forceps (Model 470171) due to increased complaints of frayed or broken grip cables on the reusable instruments. Affected devices have been distributed nationwide and internationally.
Product
8MM,MICRO BIPOLAR FORCEPS,IS4000 ¿ REF 470171
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0865-2025·2025-01-22
Reusable Surgical Instruments Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling reusable surgical instruments due to reports of frayed or broken grip cables that may affect safe operation during procedures.
Product
8MM,MEGA SUTURECUT ND,IS4000¿ REF 470309
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0949-2025·2025-01-22
Sklar Instruments ECONO STERILE surgical procedure kits recalled due to packaging defect
Sklar Instruments is recalling ECONO STERILE ALFONSO INFANT SPEC STRL sterile surgical procedure kits nationwide due to packaging issues that may breach the sterile barrier.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0840-2025·2025-01-22
Augustine HotDog Patient Warming Temperature Controller May Display Power-on Self-Test Error
Augustine Temperature Management is recalling 817 units of its HotDog Patient Warming Temperature Management Controllers for a power-on self-test error code EA POST.
Product
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0943-2025·2025-01-22
ECONO STERILE medical procedure kits recalled for potential sterile barrier breach
Sklar Instruments is recalling three models of ECONO STERILE medical procedure kits nationwide due to packaging issues that may breach the sterile barrier. No injuries or illnesses have been reported.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3) ECONO STERILE KEVORKIAN CURET W/O BAS STER25, Model Number 96-4145A; cervical
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0928-2025·2025-01-22
Sklar Instruments Recalls ECONO STERILE Gynecological Procedure Kits for Packaging Defects
Sklar Instruments is recalling ECONO STERILE gynecological procedure kits (Model 96-2478) due to packaging issues that may breach the sterile barrier and create contamination risk.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0870-2025·2025-01-22
Intuitive Surgical Clip Applier Recalled for Frayed or Broken Grip Cables
Intuitive Surgical is recalling 5,576 units of the 8MM Horizon Small Clip Applier due to complaints of frayed or broken grip cables on the reusable instruments.
Product
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0856-2025·2025-01-22
8MM Maryland Bipolar Forceps Recalled Due to Frayed Grip Cables
Intuitive Surgical is recalling 8MM Maryland Bipolar Forceps due to increased complaints about frayed or broken grip cables on these reusable surgical instruments. Approximately 7,132 units have been distributed.
Product
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0859-2025·2025-01-22
Intuitive Surgical Recalls Fenestrated Bipolar Forceps Over Frayed Grip Cables
Intuitive Surgical recalls 8MM Fenestrated Bipolar Forceps due to increased complaints about frayed or broken grip cables on 12,340 units distributed nationwide and internationally.
Product
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0844-2025·2025-01-22
Folysil Silicone Foley Catheters Recalled for Possible Sterility Issue
Coloplast recalls Folysil Silicone Foley Catheters due to a possible sterility defect detected at the manufacturing facility. The affected units may not maintain proper sterilization, posing a risk of infection.
Product
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA642
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0833-2025·2025-01-22
Cook Medical Hiatal Hernia Graft Recalled for Documentation and Labeling Errors
Cook Biotech is recalling 6 hiatal hernia grafts (Lot #LB1579758) due to incorrect Instructions for Use and wrong expiration dates on two units.
Product
Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0834-2025·2025-01-22
Cook Medical Biodesign Dural Graft Recalled for Incorrect Expiration Date and Instructions
Cook Biotech is recalling specific Cook Medical Biodesign Dural Graft devices due to incorrect expiration dates on two units and use of an incorrect Instructions for Use version.
Product
Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0955-2025·2025-01-22
Demineralized Bone Matrix Putty Recalled for Incorrect Outer Box Expiration Date
IsoTis OrthoBiologics recalls OsteoSurge 100 Demineralized Bone Matrix Putty due to incorrect expiration dates on outer packaging. The outer box date does not match the correct date on the inner tray.
Product
OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, OsteoSurge 100 Demineralized Bone Matrix, 10cc, REF 56300100.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0921-2025·2025-01-22
DRG:HYBRiD-XL Insulin Device Recalled for Calibration Failures
DRG International is recalling the DRG:HYBRiD-XL Insulin device (Model HYE-5361) due to calibration failures and out-of-specification controls that may delay assay results.
Product
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0832-2025·2025-01-22
Biodesign Otologic Butterfly Graft Recall: Incorrect Instructions and Expiration Date
Cook Medical is recalling 49 Biodesign Otologic Butterfly Graft surgical implants due to incorrect Instructions for Use version and incorrect expiration dates on product packaging. No illnesses or injuries have been reported.
Product
Cook Medical Biodesign Otologic Butterfly Graft, REF ENT-OTO-BFLY-0.4-0.6, REF G60285, Sterile.
Category
Medical Device
Distribution
2 states

How to read this listing

Filters

4076–4100 of 13449