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

2426–2450 of 5038

SevereFDA (Devices)·Z-1933-2020·2020-05-20
Philips Zenition 70 Trolley Cable Recall for Electrical Contact Failure
Philips is recalling 25 Zenition 70 systems because strain relief loss on the trolley cable can break electrical contacts, exposing live parts.
Product
Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1957-2020·2020-05-20
Siemens Cios Alpha Mobile X-Ray System Recalled for Electrical Shock Risk
Siemens is recalling four Cios Alpha mobile X-ray systems because unplugging the main cable during a clinical session can expose users to unsafe electrical voltage.
Product
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1944-2020·2020-05-20
Beckman Coulter iChem VELOCITY Urine Chemistry System Recalled for Fire Risk
Beckman Coulter is recalling iChem VELOCITY Urine Chemistry Systems due to a defect in the SATA power adapter cable that poses a risk of electrical short, smoke, or flames.
Product
iChem¿VELOCITY Urine Chemistry System-
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1960-2020·2020-05-20
Intuitive Surgical Recalls da Vinci Xi Systems Due to Arm Faults
Intuitive Surgical is recalling 74 da Vinci Xi Surgical Systems because a manufacturing variation can cause arm faults and loss of functionality during surgery.
Product
da Vinci Xi Surgical System
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1932-2020·2020-05-20
Philips Zenition 50 Medical Device Recalled for Electrical Contact Failure
Philips is recalling 25 Zenition 50 devices because strain relief loss can cause electrical contacts to break, potentially exposing live parts or losing the video signal.
Product
Philips Zenition 50, System code 718096 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1847-2020·2020-05-13
Applied Medical Recalls Bard Embolectomy Catheters Due to Tip Separation
Applied Medical Resources Corp is recalling Bard Embolectomy Catheters because the tips may separate during use, posing a risk of dislodgement in patients.
Product
Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X; CE0680DR/(01)H699CE0680DR10
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1843-2020·2020-05-13
Philips TEE Transducers Recalled Due to Temperature Measurement Failure
Philips Ultrasound Inc is recalling S8-3t transesophageal transducers that may fail to measure tip temperature correctly, potentially preventing auto-cooling and causing patient injury.
Product
Transducer S8-3t UDI (01)00884838073524 REF 989605431171 Can be used as accessory with: EPIQ 7, Affiniti 70, EPIQ 5, EPIQ CVxi Ultrasound systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocard
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1863-2020·2020-05-13
Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Thoracoabdominal, Product Code: M00202175428T0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1915-2020·2020-05-13
ICU Medical Recalls IV Administration Sets with Potential Drop Cannula Error
ICU Medical is recalling 675 IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking under-delivery of critical medication.
Product
REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R, UDI: (01)00887709088139
Category
Medical Device
Distribution
44 states
SevereFDA (Devices)·Z-1865-2020·2020-05-13
Maquet Hemashield Vascular Grafts Recalled for Potential Seam Holes
Maquet Cardiovascular is recalling specific Hemashield Platinum vascular grafts due to potential small holes at seam lines that could cause intra-operative bleeding.
Product
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-Angled 4 Branch, Product Code: M00202175730AP0 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1792-2020·2020-05-13
Argon Medical Devices Recalls 0.035 Inch Guidewires Due to Tissue Perforation Risk
Argon Medical Devices is recalling specific 0.035-inch guidewires because the soft tip stiffness caused tissue perforation. The affected units were distributed to several countries outside the US.
Product
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1912-2020·2020-05-13
ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
ICU Medical is recalling IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.
Product
REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211
Category
Medical Device
Distribution
44 states
SevereFDA (Devices)·Z-1913-2020·2020-05-13
ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula
ICU Medical is recalling 14,000 IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.
Product
REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00887709077058
Category
Medical Device
Distribution
44 states
SevereFDA (Devices)·Z-1911-2020·2020-05-13
ICU Medical Recalls Veterinary IV Administration Sets with Incorrect Drop Cannula
ICU Medical is recalling veterinary IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of medication.
Product
REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475
Category
Medical Device
Distribution
44 states
SevereFDA (Devices)·Z-1842-2020·2020-05-13
Philips Recalls Transesophageal Ultrasound Transducers Due to Temperature Measurement Defect
Philips Ultrasound Inc is recalling S7-3t transesophageal transducers because a programming error prevents the system from measuring tip temperature, which may stop auto-cooling and cause patient injury.
Product
Transducer S7-3t UDI (01)00884838067530 REF 989605439232 Used as accessory with: iE33, HD11 Ultrasound Systems - Product Usage: Diagnostic ultrasound imaging or fluid flow analysis of the human body - particularly transesophageal echocardiography (TEE) studies
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1920-2020·2020-05-13
ICU Medical Recalls 10 Drop Primary IV Sets Due to Cannula Error
ICU Medical is recalling 50 units of 10 Drop Primary IV Sets because they may contain 15 drops/mL cannulas, risking under-delivery of critical medications.
Product
REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709059108
Category
Medical Device
Distribution
44 states
SevereFDA (Devices)·Z-1791-2020·2020-05-13
Argon Medical Devices Recalls 0.035 Inch Guidewires Due to Tissue Perforation
Argon Medical Devices is recalling specific 0.035-inch guidewires because the stiffness of the soft end caused tissue perforation. The affected units were distributed to several countries outside the United States.
Product
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1900-2020·2020-05-13
Howmedica Recalls Cortoss Bone Augmentation Material Due to Temperature Violations
Howmedica Osteonics Corp. is recalling 115 units of Cortoss Bone Augmentation Material because shipments were transported outside required refrigerated temperature conditions.
Product
Cortoss Bone Augmentation Material, Catalog Nos. 2101-0005 and 2101-0010
Category
Medical Device
Distribution
15 states
SevereFDA (Devices)·Z-1848-2020·2020-05-13
Applied Medical Dual Lumen Graft Cleaning Catheter Recall for Tip Separation
Applied Medical Resources Corp is recalling 28,799 Dual Lumen Graft Cleaning Catheters due to reports of tip separation during use, which may expose patients to unintended dislodgement.
Product
Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1806-2020·2020-05-06
Philips TraumaDiagnost X-Ray System Recalled Due to Potential Shaft Failure
Philips North America is recalling 346 TraumaDiagnost X-Ray systems because a shaft may break due to material fatigue, causing the arm to fall and potentially injure patients or staff.
Product
Philips TraumaDiagnost- a Stationary X-Ray System (Bucky System) Model: 720013 - Product Usage: general radiography.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1836-2020·2020-05-06
Radiometer ABL800 FLEX Blood Gas Analyzer Recall for Power Supply Defect
Radiometer Medical ApS is recalling two ABL800 FLEX analyzers in California due to a power supply defect that may cause treatment delays and serious health risks.
Product
ABL800 FLEX model number 393-800 and 393-801, UDI:(01)05700693938004
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1825-2020·2020-05-06
Elekta MONACO RTP System Recalled for Potential Inaccurate Radiation Dose Delivery
Elekta Inc is recalling 96 MONACO RTP systems because the software may alter contour shapes, potentially resulting in inaccurate radiation dose delivery to patients.
Product
Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1768-2020·2020-04-29
Acutus Medical Recalls Rhythm Xience Guider Catheter Introducers Due to Foreign Material
Acutus Medical Inc is recalling 108 units of Rhythm Xience Guider Catheter Introducers because manufacturing defects may have left foreign material particulates on the devices.
Product
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, RxOnly
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-1786-2020·2020-04-29
Degania Recalls Temperature Sensing Foley Catheters Due to Inspection Failures
Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters because inadequate incoming inspection practices were used on the thermistor sensors.
Product
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1746-2020·2020-04-29
Wilson-Cook Recalls HEMO-10 Hemospray Endoscopic Hemostat Devices
Wilson-Cook Medical is recalling HEMO-10 Hemospray Endoscopic Hemostat devices because the handle or activation knob may crack or break, potentially causing the carbon dioxide cartridge to exit the handle.
Product
HEMO-10 Hemospray Endoscopic Hemostat
Category
Medical Device
Distribution
Distributed nationwide

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