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

2176–2200 of 13381

SevereFDA (Devices)·Z-2663-2025·2025-10-08
Siemens MAGNETOM Spectra MRI system recall for ice blockage
Siemens Medical Solutions is recalling 3 MAGNETOM Spectra MRI systems worldwide due to a potential ice blockage in the magnet venting system that could prevent helium gas from escaping and cause pressure buildup.
Product
MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model Number: 10655588.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2661-2025·2025-10-08
Siemens MRI Helium Containment Rupture Risk from Vent Blockage
Siemens MAGNETOM Skyra fit MRI systems may have ice blockage in the venting system preventing helium gas escape during quench events, risking containment rupture and helium leak into the scanning room.
Product
MAGNETOM Skyra fit. Model Number: 10849580.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2610-2025·2025-10-08
Reprocessed Livewire Electrophysiology Catheters Recalled for Residual Particulates
Reprocessed electrophysiology catheters may contain residual particulates, potentially causing infection, inflammation, blood clots, or embolism. The FDA classified this Class I recall affecting 7,913 units.
Product
Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 401932RH 401933RH 401934RH 401938RH 401939RH 401940RH 401941
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2617-2025·2025-10-08
Draeger Atlan Anesthesia Workstation Recalled for Ventilator Malfunction
Draeger is recalling 223 Atlan A350XL anesthesia workstations due to potential ventilator failures. The devices may fail to provide mechanical ventilation before or during use, posing a risk to patient safety.
Product
Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 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 ve
Category
Medical Device
Distribution
25 states
SevereFDA (Devices)·Z-2670-2025·2025-10-08
Medline Catheter Valve Kits Recalled for Shape-Retention Defect
Medline is recalling 828 units of VALVE PACK-LF catheter kits because the catheter may not retain its shape, potentially causing device malfunction.
Product
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2656-2025·2025-10-08
MAGNETOM Cima.X MRI System Recall for Potential Helium Leak Risk
Siemens is recalling the MAGNETOM Cima.X MRI system worldwide due to potential ice blockage in the magnet venting system. During a quench, helium gas may fail to escape, potentially causing pressure buildup and leak into the scanning room.
Product
MAGNETOM Cima.X (DE). Model Number: 11647158.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2612-2025·2025-10-08
Reprocessed Electrophysiology Catheters Recalled for Residual Particulate Risk
Medline is recalling over 7,900 reprocessed electrophysiology catheters due to potential residual particulates on patient-contacting surfaces that could cause infection or blood clots.
Product
Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies; Medline Item Numbers 81102RH 81104RH 81107RH 81174RH 81402RH 81404RH 81405RH 81472RH 81473RH 81474RH 81531RH 81532RH
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2665-2025·2025-10-08
Siemens MAGNETOM Verio Dot MRI Systems Recalled for Helium Leak Risk
Siemens is recalling 59 MAGNETOM Verio Dot MRI systems due to potential ice blockage in the helium venting system. This could cause pressure buildup and helium leak into the scanning room.
Product
MAGNETOM Verio Dot. Model Number: 10684333.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2658-2025·2025-10-08
Siemens MAGNETOM Lumina MRI system: potential helium venting system blockage
Siemens is recalling MAGNETOM Lumina MRI machines due to potential ice blockage in the helium venting system that could cause pressure buildup and rupture the helium containment, releasing gas into the scanning room.
Product
MAGNETOM Lumina (DE). Model Number: 11344916.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0020-2026·2025-10-08
NES Laser Atherectomy Catheter Recalled for Sterile Packaging Breach Risk
Northeast Scientific is recalling 165 units of the NES Reprocessed Laser Atherectomy Catheter due to potential breaches in sterile barrier packaging that could compromise sterility assurance.
Product
NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-152. 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-2673-2025·2025-10-08
HEYEX PACS Medical Imaging Software Recall: Measured Values May Be Inaccurate
Medical imaging software HEYEX PACS versions 2.6.0 to 2.6.8 may report measured values smaller than actual area. 474 units distributed nationwide; FDA Class II recall.
Product
Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220). Device Type: Software (Medical Image Management, Picture Archiving and Communication System)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2637-2025·2025-10-08
JETT Blood Flow Occlusion Devices Recalled for Manufacturing Defect
North American Rescue is recalling 552 JETT devices used to control bleeding in limbs due to a potential manufacturing defect that may compromise device performance during use.
Product
JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550; KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519; KIT, MULTI MISSION EXPEDITIONARY RESPONSE - MMERK, REF: 85-2420; KIT, TCCC SKILLS/IFAK
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0016-2026·2025-10-08
Getinge Model 88-5 Washer-Disinfector Recalled for Overheat Risk
Getinge 88-Series Washer-Disinfector Model 88-5 units may overheat if the circulation pressure calibration was not performed correctly and the low-pressure alarm fails to trigger. 902 units are affected worldwide.
Product
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2640-2025·2025-10-08
Hip Stem Implants Subject to Product Mix Recall
Howmedica Osteonics has recalled EXETER V40 hip stem implants due to packaging errors where boxes may contain the wrong model or lot number. Affected units should be verified with surgical providers.
Product
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0025-2026·2025-10-08
Laser Atherectomy Catheter Recall Due to Sterile Packaging Defects
Northeast Scientific is recalling the NES Reprocessed Turbo Elite Laser Atherectomy Catheter due to potential breaches in sterile barrier packaging. The defect could compromise sterility assurance on 141 units distributed nationwide.
Product
NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-159. 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-0013-2026·2025-10-08
Allura Xper FD20/20 Operating Room Table Battery Issue Affects Startup
Philips recalled 5 Allura Xper FD20/20 OR tables because the BIOS battery depletes faster than designed, preventing the system from starting. No user warnings appear before the battery fails.
Product
Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0007-2026·2025-10-08
Operating Room Table BIOS Battery Depletion Prevents System Startup
The BIOS battery in Philips Allura Xper FD20 operating room tables may deplete faster than expected, preventing system startup. No warning messages appear before depletion.
Product
Allura Xper FD20 Biplane OR Table; Model Numbers: (1) 722020, (2) 722025; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0022-2026·2025-10-08
Medical Catheter Recalled for Potential Sterile Barrier Packaging Breaches
Northeast Scientific is recalling 795 units of the NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter due to potential breaches in sterile barrier packaging that could compromise device sterility.
Product
NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number: R-410-154. 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0023-2026·2025-10-08
NES Reprocessed Laser Atherectomy Catheter Recalled for Sterile Packaging Breach
Northeast Scientific Inc. is recalling 1,019 units of its NES Reprocessed 1.4mm Turbo Elite Laser Atherectomy Catheter (Model R-414-159) due to potential sterile barrier breaches that could compromise device sterility.
Product
NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. 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-0017-2026·2025-10-08
Dental Implants Recalled Due to Improper Storage Conditions
S.I.N. Implant System dental implants were imported under improper temperature and storage conditions that may have damaged packaging and compromised product quality. Affected implants were distributed nationwide.
Product
IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2638-2025·2025-10-08
Venclose digiRF Generator Software Version 3.35 Causes False Positive Catheter Failures
The Venclose digiRF Generator software version 3.35 mistakenly disables properly working catheters due to faulty temperature checks. Approximately 1,725 units distributed in the US and Malaysia are affected.
Product
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0036-2026·2025-10-08
GORE ACUSEAL Vascular Graft Risk of Delamination and Reduced Blood Flow
W.L. Gore is recalling GORE ACUSEAL Vascular Grafts due to risk of delamination, which can reduce blood flow, cause cannulation difficulties, and lead to bleeding or bruising. Instructions for Use will be updated with enhanced warnings.
Product
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-2613-2025·2025-10-08
Reprocessed Electrophysiology Catheters Recalled for Residual Particulate Contamination
Medline is recalling 7,913 reprocessed ICE catheters due to residual particulates on patient-contacting surfaces. These particles may cause infection, blood clots, or potentially fatal embolism.
Product
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0027-2026·2025-10-08
Aesculap Elan 4 Duraguard Surgical Instruments Mislabeled Long and Standard
Aesculap AG recalled three Elan 4 Fixed Duraguard surgical instruments that were mislabeled. Units marked 'Long' were actually 'Standard' and vice versa, which could affect surgical procedures.
Product
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0033-2026·2025-10-08
Medtronic Simplera Sensor cap may not adhere properly to sensor
Medtronic is recalling the Simplera Sensor because the device cap label may not adhere properly to the sensor, potentially compromising its sterility. This increases the risk of infection.
Product
Medtronic, Simplera Sensor, REF: MMT-5100JD1
Category
Medical Device
Distribution
0 states

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2176–2200 of 13381