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

2301–2325 of 27375

HighFDA (Devices)·Z-2472-2025·2025-09-03
Hip and knee procedure packs recalled over unconfirmed sterilization assurance requirements
American Contract Systems anterior hip, total knee and hip prosthesis packs are recalled because the firm cannot confirm that product sterilization assurance requirements were met. 588 units are affected.
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK, MODEL/ITEM NUMBER HSTH03N; 4)DTC ANTERIOR HIP PACK (PS 209459), MODEL/ITEM NUM
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2415-2025·2025-09-03
Infusion pumps recalled because degrading grease may cause excessive therapy delivery
Six Baxter Spectrum IQ Infusion Pumps are recalled because grease applied to the cam and motor gears may break down, causing premature wear and potentially excessive therapy.
Product
Spectrum IQ Infusion Pump, Product Code 3570009
Category
Medical Device
Distribution
2 states
CriticalFDA (Devices)·Z-2325-2025·2025-08-27
ENDOTAK RELIANCE defibrillation leads recalled over coil calcification and rising LVSI
ENDOTAK RELIANCE G/SG transvenous defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils.
Product
ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter defibrillator (non-CRT); Model Nos. 0160, 0161, 0162, 0163, 0164, 0165, 0166, 0167, 0170, 0171, o182, 0173, 0174, 0175, 0176, 0177, 0180, 0182, 0183, 0184, 0185, 0186, 0187
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2328-2025·2025-08-27
Hamilton C6 ventilators recalled over circuit board defect interrupting ventilation
Hamilton C6 ventilators are recalled over a mechanical defect on a printed circuit board that may cause the device to fail at startup or interrupt ventilation during use. 1,040 systems are affected.
Product
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optionally infants and neonates.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2327-2025·2025-08-27
RELIANCE 4-FRONT defibrillation leads recalled over rising LVSI measurements and coil calcification
RELIANCE 4-FRONT defibrillation leads are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils, which may lead to early lead replacement.
Product
RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead, Permanent Defibrillator Electrodes; Model Nos. 0654, 0655, 0657, 0658, 0682, 0683, 0685, 0686, 0692, 0693, 0695, 0696
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2326-2025·2025-08-27
ENDOTAK RELIANCE leads with 4-SITE connector recalled over coil calcification
ENDOTAK RELIANCE G/SG defibrillation leads with the 4-SITE connector are recalled because affected models may show gradually rising LVSI measurements linked to calcification of the defibrillation coils.
Product
ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent Defibrillator Electrodes; Model Nos. 0282, 0283, 0285, 0286, 0292, 0293, 0295, 0296
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2338-2025·2025-08-27
Electrosurgical generators recalled over system error causing reboots during use
The ESG-410 Electrosurgical Generator is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 155 units are affected.
Product
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2344-2025·2025-08-27
OtoLase starter kits recalled over potentially unsterilized product labeled as sterile
OtoLase Starter Kits, UPN AC-2003748, batches 32644549 and 32769567, are recalled because finished product labeled as sterile may not have been sterilized. 13 units are affected.
Product
OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2339-2025·2025-08-27
Legacy electrosurgical generators recalled over system error triggering repeated device reboots
The ESG-410 Legacy Electrosurgical Generator, model WA91307C, is recalled because it may display an E0662 System Error followed by a single automatic reboot or a continuous reboot loop. 434 units are affected.
Product
Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410. Model Number: WA91307C. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instr
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2336-2025·2025-08-27
Estrone diagnostic kits recalled over rare falsely high or low results
Estrone RIA kits, catalog number DSL8700, are recalled because certain lots may rarely give falsely high or falsely low patient results. 279 units are affected.
Product
Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro diagnostic manual medical device used by healthcare professionals for the quantitative measurement of estrone in human serum and plasma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2340-2025·2025-08-27
Deep brain stimulation burr hole kits recalled over retaining clip closing resistance
Burr Hole Cover Kits used with the Vercise Deep Brain Stimulation System are recalled because resistance closing the retaining clip may cause procedural delay or lead migration requiring further surgery. 24,583 units are affected.
Product
Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2331-2025·2025-08-27
Bayonet injection needles recalled after showing elevated cytotoxicity in testing
Bayonet Luer-Lock injection needles, models 50-353-23 and 50-345-23, are recalled because affected product showed elevated cytotoxicity values, which may present a risk of intolerance or allergic reaction.
Product
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2329-2025·2025-08-27
Endoscopy video processors recalled over hot light guide and thermal injury risk
Pentax Medical EPK-i8020c video processors are recalled after reports of darkened images, smoke-like steam and a hot endoscope light guide that may cause thermal injury to the patient's mucous membrane. 144 units are affected.
Product
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Category
Medical Device
Distribution
20 states
CriticalFDA (Devices)·Z-2273-2025·2025-08-20
Carotid stent delivery systems recalled over resistance during withdrawal after deployment
Certain batches of the Carotid WALLSTENT Monorail Endoprosthesis are being removed after complaints of greater than anticipated resistance withdrawing the delivery system. The most serious potential consequence is stroke.
Product
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system. Material numbers: H7493915010240 CAROTID WALLSTENT MONORAIL 10.0-24; H7493915010310 CAROTID WALLSTENT MONORAIL 10.0-31; H749391506220 CAROTID WALLSTENT MONORAIL
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2290-2025·2025-08-20
HeartMate mobile power unit cords recalled over locking feature that may disconnect
Abbott is recalling 53 HeartMate Mobile Power Unit AC power cords, model 107760, because a misaligned V-Lock may not engage and can allow an unintended disconnect. The FDA classified this as Class I.
Product
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device desi
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2229-2025·2025-08-20
Non-continuous ventilators recalled over programming error causing incorrect device configuration
DreamStation Auto non-continuous ventilators are recalled because the devices may carry a programming error resulting in an incorrect device configuration. The FDA classified the action as Class I.
Product
DreamStation Auto. Non-Continuous Ventilator.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2181-2025·2025-08-20
Manual resuscitators recalled because blocked manometer port may disable pressure gauge
Ambu is recalling 87,156 SPUR II adult resuscitators because the manometer port may be blocked, leaving the manometer non-functional. The FDA classified the action as Class I.
Product
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2173-2025·2025-08-20
Infusion pumps recalled over underinfusion when flow rate more than doubles
Baxter is issuing an urgent correction for 36,705 Novum IQ large volume pumps because the pump may underinfuse when moving to a flow rate more than double the current one.
Product
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2291-2025·2025-08-20
HeartMate mobile power unit cords may disconnect from a misaligned lock
HeartMate Mobile Power Units are being recalled because misaligned V-Lock features on the power cords prevent the locking mechanism engaging properly and may cause unintended disconnect. 604 units affected.
Product
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2228-2025·2025-08-20
DreamStation Auto BiPAP units may hold an incorrect device configuration
DreamStation Auto BiPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 8 units are affected.
Product
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2227-2025·2025-08-20
DreamStation Auto CPAP units may hold an incorrect device configuration
DreamStation Auto CPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 57 units are affected.
Product
DreamStation Auto CPAP. Non-Continuous Ventilator.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2285-2025·2025-08-20
Knee tibial insert catalog number 341-16-704 recalled for mislabeled size or side
Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, because the implants carry incorrect size or side labeling.
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2322-2025·2025-08-20
Thyroglobulin assay reagent recalled after lot generated erroneously high patient results
Access Thyroglobulin assay reagent lot 439163 is recalled because it may generate erroneously high patient results, which could prompt unnecessary imaging or therapy changes. 453 units are affected.
Product
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2278-2025·2025-08-20
FARAWAVE ablation catheters may have cracks in the distal electrode bands
FARAWAVE 1.0 Pulsed Field Ablation Catheters are being recalled because specific manufacturing equipment may have caused cracks in the electrode bands on the catheter's distal end. 445 units affected.
Product
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2025·2025-08-20
Custom manifold kit tubing may separate and trap air in line
Custom Manifold Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 6,327 units affected.
Product
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
Category
Medical Device
Distribution
Distributed nationwide

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2301–2325 of 27375