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

2501–2525 of 27375

HighFDA (Devices)·Z-2010-2025·2025-07-02
Altivate Reverse Torx Peripheral Screws Package Labeling Mismatch
Encore Medical is recalling Altivate Reverse Torx Peripheral screws because the package labeling lists a different screw size than what is actually included in the package.
Product
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm Model/Catalog Number: 506-04-118 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1999-2025·2025-07-02
BD Insyte Autoguard Shielded IV Catheter needle retraction failure recall
Becton Dickinson is recalling BD Insyte Autoguard Shielded IV Catheters (REF 381423, 22GA X 1.00 IN) due to the possibility that the catheter needle may be slow to retract or fail to retract entirely.
Product
REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X 25 MM) 35mL/min, STERILEEO, RxONLY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2030-2025·2025-07-02
GE Healthcare Versana Ultrasound Systems display incorrect fetal weight data
GE Healthcare Versana Premier R3 and LOGIQ F R3 ultrasound systems can display previous obstetric patient data in fetal weight measurement reports, potentially leading to incorrect clinical decisions based on inaccurate fetal size and growth calculations.
Product
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2007-2025·2025-07-02
BD Insyte Autoguard Shielded IV Catheter needle retraction failure
Becton Dickinson is recalling BD Insyte Autoguard Shielded IV Catheters (20 GA x 1.16 in, REF 381434) because the catheter needle may be slow to retract or fail to retract entirely.
Product
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2006-2025·2025-07-02
BD Insyte Autoguard Winged Shielded IV Catheter Needle Retraction Issue
Becton Dickinson is recalling BD Insyte Autoguard Winged Shielded IV Catheters (Lot# 4282308) because the catheter needle may be slow to retract or fail to retract entirely following use.
Product
REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2005-2025·2025-07-02
BD Insyte Autoguard Shielded IV Catheter needle retraction malfunction
Becton Dickinson is recalling a specific lot of BD Insyte Autoguard Shielded IV Catheters due to reports that the catheter needle may be slow to retract or fail to retract.
Product
REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2008-2025·2025-07-02
Altivate Reverse Torx Peripheral Screw labeling mismatch recall
Encore Medical is recalling Altivate Reverse Torx Peripheral Screws because package labeling indicates a different screw size than the product actually included. This mismatch could lead to incorrect surgical implantation.
Product
Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthr
Category
Medical Device
Distribution
18 states
CriticalFDA (Devices)·Z-1944-2025·2025-06-25
Dexcom G7 Glucose Receiver recalled due to defective foam or assembly error
Dexcom, Inc. is recalling Dexcom G7 Glucose Receiver units due to defective foam or assembly error that may cause the speaker to lose contact with the circuit board, preventing audible alerts for low or high blood glucose.
Product
Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013 (MT26403-1) , STK-GT-019 (MT26403-4) , STK-GT-100 (MT26403-2), STK-GT-109 (MT26403-2) , STK-GT-113 (
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1946-2025·2025-06-25
Dexcom One Continuous Glucose Monitoring System Receiver Speaker Defect
Dexcom, Inc. is recalling Dexcom One Continuous Glucose Monitoring System receivers due to potential defective foam or assembly errors that may cause the speaker to lose contact with internal components, resulting in missed audible alerts for dangerous blood glucose levels.
Product
Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1945-2025·2025-06-25
Dexcom One+ Continuous Glucose Monitoring System Receiver Speaker Defect
Dexcom, Inc. is recalling 26,291 units of the Dexcom One+ Continuous Glucose Monitoring System due to defective foam or assembly errors that may prevent audible alerts for low or high blood glucose levels, potentially leading to seizures, loss of consciousness, or death.
Product
Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1943-2025·2025-06-25
Dexcom G6 Glucose Receiver recalled for missed audible alerts
Dexcom G6 Glucose Receiver units may have defective foam or assembly errors that disable audible alerts for dangerously low or high blood glucose, risking seizures, loss of consciousness, or death.
Product
Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1902-2025·2025-06-25
Cook Beacon Tip Angiographic Catheters Recalled for Tip Separation Risk
Cook Incorporated is recalling specific lots of Beacon Tip 5.0 Fr Angiographic catheters due to the risk that the catheter tip may separate during use. The affected catheters were distributed worldwide.
Product
Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coati
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1992-2025·2025-06-25
Fresenius 5008X HDF Hemodialysis Blood Tubing Sets recalled for potential blood leaks
Fresenius Medical Care is recalling 5008X HDF Hemodialysis Blood Tubing Sets due to potential blood leaks between the venous chamber and tubing. The recall affects hemodialysis, hemodiafiltration, hemofiltration, and isolated ultrafiltration procedures nationwide.
Product
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number: 03-5100-7C. c. 5008X Standard HDF Bloodline w/ Twister, Model Number: 03-5150-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1977-2025·2025-06-25
Fitbone Trochanteric Nail may bend during insertion and require replacement
Orthofix Srl is recalling Fitbone Trochanteric Nails (Lot B4771336 and B4771337) because the implant may bend at the distal tail during insertion, potentially requiring replacement.
Product
REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1981-2025·2025-06-25
UROSKOP Omnia X-ray System Model 10094910 Frequency Inverter Overheating Recall
Siemens is recalling 95 units of the UROSKOP Omnia X-ray system nationwide due to a resistor in the frequency inverter that may overheat and potentially ignite the plastic housing.
Product
UROSKOP Omnia. Model Number: 10094910
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1987-2025·2025-06-25
Biomet 3i Certain-Compatible 4.1mm Milled Titanium Dental Abutments
Preat Corp is recalling Biomet 3i Certain-compatible 4.1mm Milled Titanium Abutments (Model 9001767-F) due to manufacturing defects that may cause improper screw engagement. The screw seat was positioned too high, potentially compromising the attachment of mating screws to the underlying implant.
Product
Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1988-2025·2025-06-25
Optima Coil System embolization coils recalled for defective radiopaque marker
BALT USA is recalling the Optima Coil System because the radiopaque marker was not visible during angiography and was not manufactured to specification.
Product
Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 008
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1991-2025·2025-06-25
ICU Medical Plum Solos Infusion Pump Software Safety Defect Recall
ICU Medical is recalling Plum Solos infusion pumps (Item 400011001) with software version 1.1.1 due to a workflow that may bypass the Maximum Dose Limit alert, which is designed to prevent overdose. The defect affects 214 units distributed across nine US states and the Philippines.
Product
ICU Medical Plum Solos, Item number 400011001; infusion pump
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1989-2025·2025-06-25
Prestige Coil System implantable devices recalled for manufacturing defect
BALT USA is recalling Prestige Coil System implantable embolization devices because radiopaque markers on some units were not manufactured to specification and were not visible during angiography.
Product
Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 0081006
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1990-2025·2025-06-25
ICU Medical Plum Duo Infusion Pump Software Dose Limit Issue
ICU Medical is recalling Plum Duo infusion pumps with software version 1.1.1 because a workflow may bypass the Maximum Dose Limit alert, potentially allowing unsafe medication doses to be programmed.
Product
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1985-2025·2025-06-25
Surgical Mesh Recalled for Potential Residual Adhesive Material
Chamberlain Technologies LLC is recalling SURGIMESH XB surgical mesh due to potential residual adhesive material on the mesh surface. The affected product was distributed to Illinois, Nebraska, and California.
Product
SURGIMESH XB, Polymeric Surgical Mesh, X-Large Ellipse Barrier Mesh, Model/Catalog Number: Tintra E-3030
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1980-2025·2025-06-25
Portable Oxygen Concentrator with Erroneous Calibration Values
Ohio Medical Corporation is recalling 36 units of the GCE HEALTHCARE Zen-O lite portable oxygen concentrator due to erroneous calibration values that may cause the device's alarm for low oxygen purity to function incorrectly as the device ages.
Product
GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1982-2025·2025-06-25
Siemens UROSKOP Omnia Max frequency inverter fire risk recalled
Siemens is recalling UROSKOP Omnia Max medical devices due to a resistor in the frequency inverter that may overheat and ignite the plastic housing. Twenty-five units distributed nationwide are affected.
Product
UROSKOP Omnia Max. Model Number: 10762473
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1930-2025·2025-06-18
Philips Intera 1.5T Achieva Nova MRI Systems Gradient Coil Fire Risk
Philips is recalling certain Intera 1.5T Achieva Nova MRI systems due to a gradient coil component that can overheat, potentially causing smoke or fire with risk of burns, smoke inhalation, or asphyxia.
Product
Intera 1.5T Achieva Nova Product Number: 781172;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1969-2025·2025-06-18
Azurion R1.x and R2.x X-ray systems software communication issue
Philips Medical Systems has recalled Azurion R1.x and R2.x X-ray systems worldwide due to a software issue that can cause loss of imaging functionality and delay treatment, potentially resulting in serious harm or death in patients undergoing urgent or complex interventions.
Product
Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: Al
Category
Medical Device
Distribution
Distributed nationwide

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2501–2525 of 27375