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

4751–4775 of 39987

SevereFDA (Devices)·Z-0824-2025·2025-01-22
ESSENTIO DR Pacemakers May Malfunction Due to Battery Impedance Issue
Boston Scientific is recalling certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.
Product
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0905-2025·2025-01-22
Olympus MAJ-891 Forceps Recalled for Potential Biomaterial Retention During Reprocessing
Olympus recalls the MAJ-891 endoscope forceps/irrigation plug nationwide because improper reprocessing may leave biomaterial inside the device, creating a contamination risk.
Product
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0902-2025·2025-01-22
VITROS DGXN Slides Recalled Due to Hemoglobin Interference in Digoxin Measurement
VITROS DGXN Slides are recalled because hemoglobin can interfere with digoxin measurement, producing artificially low results. Approximately 1,541 units were distributed in the US and internationally.
Product
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxi
Category
Medical Device
Distribution
Distributed nationwide
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-0906-2025·2025-01-22
BD Pyxis MedStation ES software issue may delay medication dispensing
A software bug in BD Pyxis MedStation ES medication dispensing cabinets may prevent staff from locating alternate supply locations, potentially delaying patient therapy.
Product
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Category
Medical Device
Distribution
Distributed nationwide
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-0837-2025·2025-01-22
Karl Storz Biopsy and Grasping Forceps Recalled Due to Sterility Validation Failure
Karl Storz Endoscopy is recalling 285 units of optical biopsy and grasping forceps (REF 723400) distributed across 31 US states due to failure of manual cleaning validation, which compromises sterility assurance.
Product
Karl Storz - Endoskope - REF 723400 - Optical Biopsy and Grasping Forceps, CE
Category
Medical Device
Distribution
32 states
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-0914-2025·2025-01-22
Cardinal Health Fetal Surgery Kits Recalled for Endotoxin Contamination Risk
Cardinal Health is recalling Presource fetal surgery kits due to potential endotoxin contamination in non-sterile surgical strips and patties, which could pose infection risk.
Product
Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7 5 ) KIT, FETAL SURGERY , Catalog Number PB11
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0862-2025·2025-01-22
Surgical Retractor Grip Cables May Fray or Break During Use
Intuitive Surgical is recalling 738 units of the 8MM Atrial Retractor (Model 470246) due to reports of frayed or broken grip cables on reusable instruments. The defect could compromise instrument performance during surgical procedures.
Product
8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-0823-2025·2025-01-22
PROPONENT DR Pacemaker Recalled for Unexpected Safety Mode Risk
Boston Scientific is recalling certain PROPONENT DR pacemakers built before September 2018 due to latent battery impedance that could cause unexpected Safety Mode initiation during normal operation.
Product
PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0954-2025·2025-01-22
Surgical instrument kits recalled for potential sterile packaging defects
Sklar Instruments is recalling 41,850 units of ECONO STERILE surgical procedure kits due to packaging defects that may compromise the sterile barrier, affecting multiple clamp and hemostat models used in general orthopedic surgery.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3) ECONO STERILE OLSEN-HEGAR NH 5.5" STRL CS/25, Model Number 96-2355A; 4) ECO
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-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-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
52 states
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-0847-2025·2025-01-22
Intuitive Surgical Monopolar Curved Scissors Recalled for Frayed Grip Cables
Intuitive Surgical recalls 355,547 monopolar curved scissors due to increased complaints of frayed or broken grip cables on these reusable surgical instruments.
Product
8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179
Category
Medical Device
Distribution
52 states
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-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-0931-2025·2025-01-22
Medical Procedure Kits Recalled for Potential Sterile Barrier Breach
Sklar Instruments is recalling ECONO STERILE Curette Excavator surgical kits due to packaging issues that may compromise sterile barriers. Affected kits were distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2025·2025-01-22
Gynecological dilator kits recalled for potential sterile barrier compromise
Sklar Instruments is recalling ECONO STERILE gynecological dilator kits nationwide due to packaging issues that may breach the sterile barrier, potentially affecting product safety.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECONO STERILE HEGAR DILATOR 7&8MM STRL CS25Model Number 96-0962; 4) ECONO STERILE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0907-2025·2025-01-22
Panther Fusion GBS Assay Kits with Weak Cartridge Seals May Produce Invalid Results
Hologic is recalling 380 Panther Fusion GBS Assay Kits due to potential weak pouch seals on the reagent cartridge. The seals may allow invalid or incorrect test results, potentially delaying necessary treatment.
Product
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-0927-2025·2025-01-22
Sklar Instruments Recalls ECONO STERILE Trousseau Dilator Kits for Packaging Defects
Sklar Instruments is recalling ECONO STERILE trousseau dilator kits (Model 941-0191) distributed nationwide due to packaging issues that may compromise the sterile barrier. Affected healthcare providers should stop use immediately.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0845-2025·2025-01-22
X-Flow Prostatectomy Catheter Recalled for Possible Sterility Defect
Coloplast is recalling 36,369 X-Flow prostatectomy catheters due to a possible sterility issue detected at its manufacturing facility.
Product
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
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

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4751–4775 of 39987