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

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2201–2225 of 13381

HighFDA (Devices)·Z-0024-2026·2025-10-08
Laser atherectomy catheter recalled for sterile barrier packaging defects
Northeast Scientific is recalling NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheters due to potential breaches in sterile barrier packaging. A total of 616 units were distributed nationwide.
Product
NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-156. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cle
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0021-2026·2025-10-08
FDA Recalls Laser Atherectomy Catheter Due to Sterile Barrier Breach Risk
Northeast Scientific is recalling the NES Reprocessed Turbo Elite Laser Atherectomy Catheter due to potential breaches in the sterile barrier packaging. The compromised sterility could increase infection risk during vascular procedures.
Product
NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not cl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2639-2025·2025-10-08
ZAP-X Radiosurgery System Software Defect May Cause Collision
A software defect in the ZAP-X radiosurgery system could cause the collimator to collide with patient shoulders or the treatment table during certain gantry movements.
Product
ZAP-X Radiosurgery System, Model: 300150
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0004-2026·2025-10-08
Operating Room Table BIOS Battery Depletes, Preventing System Startup
The Allura Xper FD10 OR Table may experience faster-than-expected BIOS battery depletion without warning, preventing system startup.
Product
Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0001-2026·2025-10-08
Cardiac imaging system may fail to start due to battery depletion
The Allura Xper FD10C cardiac imaging system may fail to start due to faster-than-expected BIOS battery depletion. No warning message appears before battery failure.
Product
Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0018-2026·2025-10-08
Laser Atherectomy Catheters Recalled for Potential Sterile Packaging Breaches
Northeast Scientific is recalling 561 NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheters due to potential breaches in the sterile barrier packaging that compromises sterility assurance.
Product
NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-152. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0014-2026·2025-10-08
Imaging device may fail to start due to BIOS battery depletion
The Allura Xper CV20 device may fail to start if the BIOS battery depletes faster than expected. No warning message is shown before the battery becomes low or depleted.
Product
Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0006-2026·2025-10-08
Medical imaging device may fail to start due to battery depletion
Philips Allura Xper FD20 Biplane medical imaging devices may have BIOS batteries that deplete faster than expected, preventing startup without warning to operators.
Product
Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0034-2026·2025-10-08
Artegraft Collagen Vascular Grafts Recalled Due to Unapproved Material Supplier
LeMaitre Vascular is recalling 28 units of Artegraft Collagen Vascular Grafts across 15 model numbers because raw bovine carotid arteries were sourced from a supplier not reviewed or approved by FDA.
Product
Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3) AG 636, (4) AG 640, (5) AG 645, (6) AG 715, (7) AG 730, (8) AG 735, (9) AG 740, (10) AG 745, (11) AG 750, (12) AG 830, (13) AG 840, (14) AG 1015, (15) AG 1030;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2671-2025·2025-10-08
VITEK 2 Test Cards Recalled for Inaccurate Susceptibility Testing Results
bioMerieux is recalling 235,269 VITEK 2 Gram-negative test cards that may produce false resistant results when testing multidrug-resistant Pseudomonas and Acinetobacter bacteria for Colistin. Distributed internationally, the cards may provide inaccurate antibiotic susceptibility information.
Product
VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. Export o
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0019-2026·2025-10-08
NES Turbo Elite Laser Atherectomy Catheter Recalled for Sterile Barrier Defect
Northeast Scientific is recalling the NES Reprocessed Turbo Elite Laser Atherectomy Catheter due to potential breaches in sterile barrier packaging that may compromise device sterility. The recall affects 173 units distributed nationwide.
Product
NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-151. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is no
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0032-2026·2025-10-08
DxC 500i Clinical Analyzer Software Defect Causes Test Status Display Errors
The DxC 500i clinical analyzer has a software bug affecting 116 units distributed internationally. When Chemistry and Immunoassay tests run simultaneously, test status may incorrectly remain 'In Progress' without error messages, causing processing delays.
Product
DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i Clinical Analyzer
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0030-2026·2025-10-08
Change Healthcare Radiology Software Version 14.2.2 Display Issue
Change Healthcare Radiology Solutions software version 14.2.2 has a display issue where radiology reports may not fully appear when viewing. Healthcare facilities should contact the manufacturer for a fix.
Product
Change Healthcare Radiology Solutions software version 14.2.2
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0011-2026·2025-10-08
Philips Allura Xper FD20/15 OR Table System Startup Failure Due to BIOS Battery Depletion
Philips is recalling certain Allura Xper FD20/15 OR Tables because the BIOS battery may deplete faster than expected, preventing the system from starting without warning. No user warnings appear before the battery becomes depleted.
Product
Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2672-2025·2025-10-08
Blood pressure monitor may trigger error message during high-pressure inflation
Schiller's Argus PB-3000 blood pressure monitor may display an error message during measurements when initial inflation pressure is set to high levels. Approximately 266 units were distributed in Montana, Wisconsin, and Illinois.
Product
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0009-2026·2025-10-08
Medical imaging device may fail to start due to rapid battery depletion
Philips Allura Xper FD20/10 fluoroscopy systems may fail to start if the BIOS battery depletes faster than designed. No warning is given before failure occurs.
Product
Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0005-2026·2025-10-08
Philips Allura Xper FD20 Fluoroscopy System BIOS Battery Depletion
Philips Allura Xper FD20 fluoroscopy systems may experience premature BIOS battery depletion, causing unexpected system startup failures. No warning messages alert users before battery depletion.
Product
Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0003-2026·2025-10-08
Philips Allura Xper FD10/10 fluoroscopy systems unable to start due to battery failure
The BIOS battery in affected Philips Allura Xper FD10/10 fluoroscopy systems may deplete faster than expected, preventing system startup. No warning messages alert users before the battery runs low.
Product
Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0026-2026·2025-10-08
Aesculap Surgical Instrument Mislabeled Standard and Long Models
The AESCULAP ELAN 4 FIXED DURAGUARD surgical instrument was mislabeled: Standard versions labeled as 'Long' and Long versions labeled as 'Standard.' The error affects units distributed to the US and multiple countries.
Product
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0015-2026·2025-10-08
Cardiac Imaging System Battery Depletion May Prevent Device Startup
Philips Cardio Vascular-Allura Centron cardiac imaging systems may have accelerated BIOS battery depletion that prevents the device from starting. Affected facilities should contact the manufacturer for battery replacement guidance.
Product
Cardio Vascular-Allura Centron; Model Numbers: 722400; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0012-2026·2025-10-08
Medical Imaging System May Fail to Start Due to Battery Depletion
Philips Allura Xper FD20/20 fluoroscopy systems may experience premature BIOS battery depletion, preventing system startup without prior warning. 115 units distributed worldwide are affected.
Product
Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0010-2026·2025-10-08
Philips Allura Xper Medical Imaging Systems Battery Depletion Recall
Philips Allura Xper FD20/15 imaging systems are recalled because BIOS batteries may deplete faster than expected, preventing system startup. No warning messages appear before battery failure occurs.
Product
Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0002-2026·2025-10-08
Philips Allura Xper FD10 May Fail to Start Due to BIOS Battery Depletion
Philips is recalling Allura Xper FD10 imaging systems due to faster-than-expected BIOS battery depletion. When depleted, the system will not start, and no warning appears before battery failure.
Product
Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0008-2026·2025-10-08
Operating Room Table Battery May Prevent System Startup
Philips Allura Xper FD20 operating room tables have BIOS batteries that may deplete faster than designed, preventing system startup without user warning.
Product
Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2567-2025·2025-10-01
Medline Medical Kits Recalled for Laryngoscope Light Failure
Medline Industries is recalling medical convenience kits containing defective Flexicare BritePro Solo Fiber Optic Laryngoscope Handles that fail to illuminate. The 596 affected units were distributed to healthcare facilities in six U.S. states.
Product
Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number ACC010381C; 2. DRAWER 5 - POSITION 3, Kit Number ACC010532; 3. DRAWER #4C ADULT, Kit Number ACC010671; 4. DRAWER #2, Kit Number ACC010728.
Category
Medical Device
Distribution
6 states

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2201–2225 of 13381