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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

2226–2250 of 13381

SevereFDA (Devices)·Z-2568-2025·2025-10-01
Impella Heart Assist Controller Units Recalled for Potential Pump Stop
Abiomed is recalling 71 Impella heart assist pump controllers with a defective pump driver circuit assembly that may cause decreased pump performance or pump stop, triggering failure alarms.
Product
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Package
Category
Medical Device
Distribution
17 states
SevereFDA (Devices)·Z-2566-2025·2025-10-01
Medline intubation kit laryngoscope handles recalled for light illumination failure
Medline is recalling specific intubation kits with Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to light illumination failure. The handles may not illuminate properly, potentially affecting visibility during intubation procedures.
Product
Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number ACC010369B; 2. ADULT ICU INTUBATION TRAY, Kit Number ACC010379A; 3. INTUBATION TRAY, Kit Number ACC010392; 4. INTUBATION KIT, Kit Number ACC010467A; 5. ADULT AIRWAY TRAY, Kit Number ACC01
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-2615-2025·2025-10-01
Hip Implant Surgical Adapter Recalled Due to Weld Defect
ORTOMA AB recalls Ortoma Inserter Adapter OTD hip surgical devices due to weld breakage between the pin and inserter holder. The defect affects 261 devices distributed in Florida and internationally.
Product
Ortoma Inserter Adapter OTD: Inserter Adapter OTD Straight REF 30-201 Model Number: 2001 UDI-DI code: 07350137521019 Inserter Adapter OTD Pinnacle Straight REF 30-202 Model Number: 1001 UDI-DI code: 07350137520593 Reamer Adapter OTD REF 30-157 Model Number: 1003 UDI-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2604-2025·2025-10-01
Philips CT 6000 Patient Support Table May Descend Unexpectedly
Philips is recalling certain CT 6000 systems because the patient support table may descend unexpectedly to the lowest position due to ball screw misalignment after replacement, creating a fall risk.
Product
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2606-2025·2025-10-01
CooperVision MyDay Toric contact lenses recalled for invalid sterilization
CooperVision is recalling one lot of MyDay Toric contact lenses distributed in four U.S. states. One manufacturing lot was processed with an invalid sterilization cycle, which could affect product sterility.
Product
MyDay Toric, stenfilcon A) Contact Lens. Model/Catalog Number: MyDay Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2628-2025·2025-10-01
Philips Allura Xper FD20 OR Table Motorized Movements May Fail
Philips Allura Xper FD20 operating room tables may lose motorized movement capability due to internal component deterioration. Manual positioning and imaging functions remain available.
Product
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2597-2025·2025-10-01
Philips CT Systems: Patient Table May Descend Unexpectedly
Philips is recalling CT systems because the patient support table may descend unexpectedly due to component misalignment after replacement, creating a risk of patient falls.
Product
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2622-2025·2025-10-01
BeneVision N1 Patient Monitor: Potential Abnormal Alarm Pause
Mindray BeneVision N1 patient monitors may activate an abnormal alarm pause, potentially preventing critical alerts. Approximately 2,278 units distributed worldwide.
Product
BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2600-2025·2025-10-01
Philips CT systems patient support table may descend unexpectedly
Philips is recalling CT systems whose patient support tables may descend unexpectedly due to ball screw misalignment. The recall affects 285 units distributed worldwide.
Product
Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2605-2025·2025-10-01
STRATAFIX Spiral PDS Plus Surgical Mesh Recalled for Potential Barb Non-Engagement
ETHICON is recalling STRATAFIX Spiral PDS Plus surgical mesh devices (Lot 104DBB) due to potential barb non-engagement that could affect tissue fixation function.
Product
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2599-2025·2025-10-01
Philips CT systems patient support table may descend unexpectedly
Philips Brilliance iCT SP CT systems (Model 728311) may experience unexpected descent of the patient support table due to ball screw misalignment after component replacement. Affected units should be serviced immediately.
Product
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2601-2025·2025-10-01
Philips IQon CT systems patient support tables may descend unexpectedly
Philips IQon Spectral CT systems' patient support tables may descend unexpectedly to the lowermost position due to ball screw misalignment after component replacement.
Product
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2596-2025·2025-10-01
Philips CT Systems Patient Support Table May Descend Unexpectedly
Philips CT systems' patient support table may unexpectedly descend to the lowest position due to ball screw misalignment after component replacement. No injuries have been reported. Affected healthcare facilities should contact Philips for guidance.
Product
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2609-2025·2025-10-01
FilmArray NGDS Warrior Panel Diagnostic Test Kits Recalled for Control Failures
Biofire Defense is recalling 130 kits of the FilmArray NGDS Warrior Panel diagnostic test due to increased risk of internal control failures when testing positive blood cultures, which may delay test results.
Product
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2629-2025·2025-10-01
Philips Allura Xper FD20 Operating Room Table Motorized Movement Failure
Philips Allura Xper FD20 operating room tables may lose motorized movement capability due to internal component deterioration. Manual positioning and imaging remain available.
Product
Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2595-2025·2025-10-01
Philips CT Systems Patient Support Table May Descend Unexpectedly
Philips CT systems' patient support tables may descend unexpectedly to the lowest position due to ball screw misalignment after component replacement. This poses a fall risk to patients.
Product
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2608-2025·2025-10-01
Voyant 1-Day Premium Toric Contact Lenses Recalled for Invalid Sterilization
CooperVision is recalling one lot of Voyant 1-Day Premium Toric contact lenses manufactured with an invalid sterilization cycle. Affected lenses are identified by carton lot 20735504301008 and blister lot 6450505898.
Product
Voyant 1-Day Premium Toric, (stenfilcon A) contact lens. Model Number: Voyant 1-Day Premium Toric. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2618-2025·2025-10-01
Extractor Pro RX Retrieval Balloon Catheter Recalled for Labeling Error
Boston Scientific is recalling 156 units of Extractor Pro RX Retrieval Balloon Catheter due to a labeling error that incorrectly describes the skive hole position relative to the balloon.
Product
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2607-2025·2025-10-01
Sofmed Breathables contact lens recall due to invalid sterilization cycle
CooperVision is recalling one lot of Sofmed Breathables contact lenses due to manufacturing with an invalid sterilization cycle. The affected lenses may not be properly sterilized and could pose a risk to eye health.
Product
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2602-2025·2025-10-01
Philips CT systems recalled for unexpected patient support table descent
Philips CT systems (Model 728324) may have patient support tables that descend unexpectedly due to ball screw misalignment after replacement, posing a fall risk.
Product
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2626-2025·2025-10-01
X-ray Fluoroscopy System Motorized Movement Failure from Internal Component Deterioration
Allura Xper FD20 X-ray fluoroscopy systems may experience internal component deterioration, causing loss of motorized movements. Manual positioning and imaging functionality remain available.
Product
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2594-2025·2025-10-01
Baxter Continu-Flo Solution Sets recalled due to tubing separation risk
Baxter Healthcare recalls one lot of Continu-Flo intravascular administration sets nationwide due to customer reports of tubing separation. Affected users should stop using the product and contact Baxter or their healthcare provider.
Product
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2621-2025·2025-10-01
Tandem t:slim X2 Insulin Pump app defect may cause therapy errors
The Tandem t:slim X2 insulin pump app may fail to communicate properly on right-to-left language phones, potentially causing incorrect insulin doses and blood sugar problems.
Product
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app)
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2627-2025·2025-10-01
Philips Allura Xper FD20 Biplane System Motorized Component Deterioration
Philips Allura Xper FD20 biplane X-ray systems may experience deterioration of internal components, causing loss of motorized movements. Manual movements and imaging functionality remain available.
Product
Allura Xper FD20 Biplane Product Codes: (1)722013, (2) 722008; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2624-2025·2025-10-01
Medical imaging system recalled due to component deterioration affecting motorized positioning
Philips Allura Xper FD10/10 X-ray systems may lose motorized positioning due to internal component deterioration. Manual positioning and imaging functions remain available.
Product
Allura Xper FD10/10 Product Codes: (1)722011, (2) 722027, (3) 722005; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
Category
Medical Device
Distribution
Distributed nationwide

Filters

2226–2250 of 13381