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

2151–2175 of 13382

HighFDA (Devices)·Z-0038-2026·2025-10-15
ClariTEE Miniaturized TEE Probe Control Reversal in 45 Units
ImaCor is recalling 45 units of the ClariTEE Miniaturized TEE probe (Model CLT-010) due to a manufacturing defect causing reversed lever control. The device's forward lever movement bends the probe tip forward instead of backward, posing a clinical hazard.
Product
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0040-2026·2025-10-15
Scleral Reinforcement Patches Recalled for Surgical Wound Separation Risk
EverPatch+ scleral reinforcement patches are recalled because the conjunctival wound closure may separate, exposing the surgical patch. This affects 180 units distributed across the US and internationally.
Product
EverPatch+, REF: 1044002, Permanent Scleral Reinforcement Matrix 1x5.0mm x 8.5 mm Shield/1 x 5.0mm x 6.5 mm Rectangle, STERILE VH202
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0107-2026·2025-10-15
FlexLab X Potassium Test System Has Unevaluated Sample Analysis Function
The FlexLab X in vitro diagnostic system includes a Sample Integrity Module function for detecting hemolysis, icterus, and lipemia in blood samples that was not evaluated by the FDA. Its use may produce erroneous test results or delays in patient results.
Product
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0120-2026·2025-10-15
PERIFIX FX Epidural Anesthesia Tray Recalled for Catheter Connector Positioning Defect
B Braun is recalling 2,760 units of PERIFIX FX Continuous Epidural Anesthesia Trays due to a potential defect where the catheter connector lid may be positioned incorrectly, which could affect proper catheter connector function.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0106-2026·2025-10-15
Diagnostic potassium test system function lacks FDA safety evaluation
Inpeco's FlexLab potassium test system includes a sample evaluation function that the FDA has not assessed for safety and effectiveness. This unevaluated function may produce incorrect test results or delays in patient care.
Product
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0118-2026·2025-10-15
Epidural catheter connector lid may be in incorrect position
B. Braun is recalling PERIFIX FX Continuous Epidural Anesthesia Trays because the catheter connector lid may be incorrectly positioned. The product was distributed nationwide.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0041-2026·2025-10-15
Optiflux Dialyzer Recall: Press-On Caps Require Proper Installation
Fresenius Medical Care is recalling Optiflux High Flux E-beam Dialyzer models nationwide because caps were changed from threaded to press-on design, requiring users to press firmly to ensure secure attachment. Improper installation may result in cap detachment and device malfunction.
Product
Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0117-2026·2025-10-15
PERIFIX FX Epidural Anesthesia Tray Catheter Connector Lid Recall
B. Braun is recalling PERIFIX FX epidural anesthesia trays due to a potential defect where the catheter connector lid may be in the incorrect position. This affects lot 0062011669 distributed nationwide.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKF. Product Description: CE17TKF PERIFIX CONTIN. EPIDURAL TRAY
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0072-2026·2025-10-15
Vascular Graft Recalled for Missing Regulatory Marks and Patient Documentation
LeMaitre Vascular is recalling Artegraft Collagen Vascular Grafts distributed internationally without CE and UKCA regulatory marks, patient leaflets, and implant cards. The devices were distributed with incorrect labeling and missing required patient information.
Product
Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M, AG740M, AG845M. The Artegraft is intended to serve as a substitute conduit for blood where bypass or replacement of occluded or diseased arterial segments is required or to establish a c
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0071-2026·2025-10-15
SYNCHRON Phosphorus Chemistry Reagent Lots Fail Calibration Before Expiration
Specific SYNCHRON Systems Phosphorus (PHOSm) reagent lots may fail calibration before expiration, delaying patient test results. Beckman Coulter is recalling 2,146 units distributed across multiple states and countries.
Product
SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Category
Medical Device
Distribution
15 states
ModerateFDA (Devices)·Z-0114-2026·2025-10-15
PERIFIX FX Epidural Anesthesia Tray Catheter Connector Lid Position Defect
B Braun is recalling PERIFIX FX Epidural Anesthesia Trays due to a defect where the catheter connector lid may be in an incorrect position. This could affect proper anesthetic delivery.
Product
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2614-2025·2025-10-08
Reprocessed cardiac ultrasound catheters recalled due to residual particulates
Medline is recalling reprocessed ACUSON AcuNav ultrasound catheters that may have residual particulates, creating risk of infection, blood clots, or embolism.
Product
Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. For imaging guidance only, not treatment delivery, during cardiac interventio
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2593-2025·2025-10-08
Medline sterile convenience kits recalled for lacking sterilization
Medline Industries recalls 88 Extremity Pack convenience kits that were labeled as sterile but did not undergo sterilization. The affected units were distributed to healthcare facilities in Florida, Maryland, New Jersey, and Tennessee.
Product
Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-2616-2025·2025-10-08
Atlan A350 Anesthesia Workstation Ventilator Failure Class I Recall
The Atlan A350 anesthesia workstation's piston ventilator may fail before use or during mechanical ventilation. FDA classified this Class I recall as affecting 530 units distributed across U.S. hospitals and internationally.
Product
Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical vent
Category
Medical Device
Distribution
25 states
SevereFDA (Devices)·Z-2666-2025·2025-10-08
MAGNETOM Verio Dot MRI Helium Leak Risk Due to Venting Defect
Siemens is recalling 78 MAGNETOM Verio Dot Upgrade MRI systems due to a potential ice blockage in the helium venting system that could cause pressurization and rupture during a quench event, potentially releasing helium into the scanning room.
Product
MAGNETOM Verio Dot Upgrade. Model Number: 10684334.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2659-2025·2025-10-08
Siemens MAGNETOM Prisma MRI Systems Recalled for Potential Helium Containment Rupture
Siemens is recalling certain MAGNETOM Prisma MRI systems (101 units worldwide) due to a potential ice blockage in the magnet venting system that could cause helium containment rupture and leak into the scanning room.
Product
MAGNETOM Prisma. Model Number: 10849582.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2592-2025·2025-10-08
Medline Sterile Medical Device Convenience Kits Recalled for Missing Sterilization
Medline Industries is recalling two sterile convenience kit models because the products were not sterilized despite being labeled as sterile. The kits were distributed to Florida, Maryland, New Jersey, and Tennessee.
Product
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BASIC CUSTOM PACK, Model Number: DYNJ61038B
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-2611-2025·2025-10-08
Medline Reprocessed Webster CS Catheter Recalled for Residual Particulates
Medline Industries recalled certain lots of reprocessed Webster CS Catheters due to residual particulates on patient-contacting surfaces that may cause infection, blood clots, or embolism.
Product
Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2655-2025·2025-10-08
Medical imaging device faces potential helium leak during emergency shutdown
A BIOGRAPH One medical imaging device may develop ice blockage in its helium venting system. During an emergency magnet shutdown, this could prevent proper gas escape and cause helium to leak into the scanning room.
Product
BIOGRAPH One (DE). Model Number: 11689172.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2657-2025·2025-10-08
MRI System Recall: Potential Helium Leak Risk from Magnet Venting Blockage
The MAGNETOM Connectom.X MRI system is being recalled due to potential ice blockages in the magnet venting system. If a blockage prevents helium from venting during operation, system rupture and helium leak into the scanning room could occur.
Product
MAGNETOM Connectom.X. Model Number: 11371480.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2662-2025·2025-10-08
MRI Scanner Helium Venting System Ice Blockage and Rupture Risk
Siemens MAGNETOM Skyra Fit MRI systems may develop ice blockages in the helium venting system. This could prevent gas escape during a quench, causing pressure buildup and potential rupture of the helium containment.
Product
MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2668-2025·2025-10-08
MRI Scanner Helium Venting System May Leak Due to Ice Blockage
Siemens MAGNETOM Vida Fit MRI scanners may develop ice blockages in the helium venting system. During a quench event, blocked vents could cause helium pressure buildup and rupture, leading to helium leaks into the scanning room.
Product
MAGNETOM Vida Fit. Model Number: 11410481.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2667-2025·2025-10-08
Medical Imaging System Helium Leak Risk Due to Ice Blockage
Siemens MAGNETOM Vida MRI systems may have ice blockage in the magnet venting system, potentially causing helium gas pressure buildup and rupture of the containment system, leading to helium leak into the scanning room.
Product
MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693, K213805, K220425, K231560.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2660-2025·2025-10-08
MRI System Helium Venting Malfunction Poses Pressure Leak Risk
Siemens MAGNETOM Skyra MRI systems may have ice blockages in the helium venting system, potentially preventing gas escape during a quench event. This could cause pressure buildup and rupture the helium containment system, releasing helium into the scanning room.
Product
MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2654-2025·2025-10-08
Biograph mMR Medical Device Magnet Venting System Ice Blockage Risk
Siemens recalls the Biograph mMR imaging device due to potential ice blockage in the magnet venting system. This could cause helium pressure build-up and containment rupture, potentially leaking helium into the scanning room.
Product
Biograph mMR. Model Number: 10433372.
Category
Medical Device
Distribution
Distributed nationwide

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2151–2175 of 13382