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

2451–2475 of 27375

HighFDA (Devices)·Z-2105-2025·2025-07-16
VersaCross transseptal sheath kits may have a punctured sterile barrier pouch
VersaCross Transseptal Sheath Kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
Product
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 SHEATH VXS2112 VERSACROSS SHEATH (63CM 45DEG D0)-J Used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, includ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2110-2025·2025-07-16
Alcon Custom Pak surgical kits may have damaged lidding compromising sterility
Alcon Custom Paks, customer-designed sterile surgical kits, are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 15,557 kits affected.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience kits intende
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2025·2025-07-16
Alcon Constellation procedure packs may have damaged lidding compromising sterility
Alcon Constellation Vision System Combined Procedure Paks are being recalled because some units within specific lots may have been damaged during manufacture in the lidding area. 89,495 units affected.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Surgical procedure pack to interface with Alcon Constellati
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2101-2025·2025-07-16
O-arm O2 imaging system gantry support may have been damaged
The O-arm O2 Imaging System is being recalled because a mechanical component supporting the gantry to the support structure may have been damaged during manufacture. 3 units affected.
Product
O-arm O2 Imaging System. Mobile X-Ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2098-2025·2025-07-16
Nuclear medicine systems may show unintended radial detector motion during scans
Varicam, Millennium VG, Millennium VG Hawkeye and Discovery VH nuclear medicine systems are being recalled because unintended radial detector motion may occur without the correct gantry software version. 21 units affected.
Product
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2103-2025·2025-07-16
VersaCross access kits may have a hole in the sterile pouch
VersaCross Access Solution kits are being recalled because of a potential hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. 14,724 units affected.
Product
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45DEG/D0) VXSK0101 VXSK (180J RF WIRE 63CM/45DEG/D1) VXSK0102 VXSK (180J RF WIRE 63CM/55DEG/D0) VXSK0103 VXSK (180P RF WIRE 63CM/45DEG/D0) VXSK0121 VXSK (180P RF WIRE 63CM/45DEG/D1)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2041-2025·2025-07-09
HardyCHROM CRE Culture Medium Recalled for Quality Control Failure
Hardy Diagnostics is recalling HardyCHROM CRE culture medium (Catalog No. G323) distributed across 22 US states and Puerto Rico. The product failed quality control testing due to breakthrough growth of Klebsiella pneumoniae.
Product
HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
Category
Medical Device
Distribution
22 states
SevereFDA (Devices)·Z-2014-2025·2025-07-09
Servo-n ventilators may measure patient circuit compliance inaccurately
The Servo-n Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 7,688 units affected.
Product
Servo-n Ventilator System. Model Number: 6694800.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2015-2025·2025-07-09
Servo-u MR Ventilator System inaccurate patient circuit compliance measurement
Servo-u MR Ventilator System (Model 6888800) may measure patient circuit compliance inaccurately due to incorrect pre-use leakage testing and incorrect active humidifier use.
Product
Servo-u MR Ventilator System. Model Number: 6888800.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2035-2025·2025-07-09
BiPAP V30 Auto ventilators are not indicated for respiratory failure
The Philips Respironics BiPAP V30 Auto Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 5,958 units affected.
Product
BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2048-2025·2025-07-09
Philips Ultrasound Transducers Recalled After Over-Refurbishment
Philips Ultrasound, Inc is recalling 5,230 Philips 3D9-3v Transducer devices because they were refurbished beyond their useful life, posing a risk of device failure during medical use.
Product
Philips 3D9-3v Transducer.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2036-2025·2025-07-09
BiPAP A30 and BiPAP Hybrid A30 Ventilators Recalled by Philips
Philips Respironics is recalling BiPAP A30 and BiPAP Hybrid A30 ventilators. The devices do not have an indication for use in patients with respiratory failure.
Product
BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg. BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2013-2025·2025-07-09
Servo-u ventilators may measure patient circuit compliance inaccurately
The Servo-u Ventilator System is being recalled because patient circuit compliance may be measured inaccurately during the patient circuit test. 874 units are affected.
Product
Servo-u Ventilator System. Model Number: 6688600.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2037-2025·2025-07-09
BiPAP A40 ventilators are not indicated for respiratory failure patients
The BiPAP A40 Ventilator is being recalled because the device does not indicate for use in patients with respiratory failure. 6 units in the US and 67,534 outside it are affected.
Product
BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2072-2025·2025-07-09
Cardiology hemodynamics software update may cause unexpected system shutdowns
Change Healthcare Cardiology Hemodynamics Software version 15.0.1 is being recalled because, following complaints, a software update may cause the software to unexpectedly shut down.
Product
Change Healthcare Cardiology Hemodynamics Software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2079-2025·2025-07-09
BD FACS 7-Color Setup Beads Recalled Due to Spectral Overlap Errors
Becton, Dickinson and Company is recalling BD FACS 7-Color Setup Beads (REF 666289, Lots 85637 and 85638) because errors in the spectral overlap factors table may prevent accurate setup of flow cytometry instruments.
Product
REF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Category
Medical Device
Distribution
37 states
HighFDA (Devices)·Z-2051-2025·2025-07-09
Philips C9-5EC Ultrasound Transducer Devices Recalled
Philips Ultrasound, Inc. is recalling Philips C9-5EC transducer devices that were refurbished beyond their useful life, which may affect device performance and safety.
Product
Philips C9-5EC Transducer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2076-2025·2025-07-09
Bard Urologist's Tray Recalled Over Incorrect French Size Labeling
C.R. Bard Inc is recalling 63 units of the Bard Urologist's Tray due to cather packaging that may contain the incorrect French size, which could affect device use.
Product
REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2043-2025·2025-07-09
Medline IV Catheters Recalled for Needle Retraction Failure
Medline Industries is recalling specific Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters because the needle may be slow to retract or fail to retract during catheter insertion.
Product
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2058-2025·2025-07-09
Philips S5-1 Ultrasound Transducers Refurbished Beyond Useful Life
Philips Ultrasound is recalling Philips S5-1 Transducers because they were refurbished beyond their useful life, which may affect device performance and safety.
Product
Philips S5-1 Transducer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2089-2025·2025-07-09
ADVIA Hematology System Control Product Recall for Platelet Value Error
Siemens Healthcare Diagnostics is recalling 3,266 units of ADVIA 120/2120/2120i 3-in-1 TESTpoint Control worldwide due to incorrect platelet value assignments that could affect test results.
Product
ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2039-2025·2025-07-09
VITROS XT 7600 Chemistry Analyzer Software Anomaly Causing Erroneous Test Results
Ortho-Clinical Diagnostics is recalling VITROS XT 7600 Integrated System analyzers due to a software anomaly that can report test results as expired when reagent shelf expiration dates are omitted during manual loading, potentially causing erroneous or delayed test results.
Product
Brand Name: VITROS; Product Name: VITROS XT 7600 Integrated System; Model/Catalog Number: (1) 6844461, (2) 6272222; Software Version: version 3.2 to version 3.8.3 (all available software versions); Product Description: In vitro diagnostic chemistry analyzer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2074-2025·2025-07-09
BD Heyman Follower Straight Tip catheters with incorrect French size packaging
C.R. Bard Inc is recalling BD Heyman Follower Straight Tip catheters because packaging may contain an incorrect French size designation, which could lead to use of the wrong catheter size.
Product
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2040-2025·2025-07-09
VITROS 4600 chemistry systems may report results using expired diluent packs
VITROS 4600 Chemistry Systems are being recalled because a software anomaly can allow results to be reported using diluent packs the system treats as expired, which can produce erroneous results.
Product
Brand Name: VITROS Product Name: VITROS 4600 Chemistry System Model/Catalog Number: (1) 6802445, (2) 6900440 Software Version: version 3.2 to version 3.8.3 (all available software versions) Product Description: In vitro diagnostic chemistry analyzer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2045-2025·2025-07-09
Medline retinal packs recalled because catheter needle may fail to retract
Medline RETINAL PACK-LF convenience kits are being recalled because the BD Insyte Autoguard catheter needle inside may be slow to retract or fail to retract during insertion. 80 units affected.
Product
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
Category
Medical Device
Distribution
Distributed nationwide

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2451–2475 of 27375