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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1176–1200 of 13381

HighFDA (Devices)·Z-1050-2026·2026-01-21
Medline Cardiac Procedure Kits Recalled Due to Stuck Check Valve in IV Administration Sets
Medline has recalled 633 kits containing B. Braun IV Administration Sets and Pump Administration Sets due to customer complaints that check valve components may become stuck in open or closed positions.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) OPEN HEART ACCESSORY CDSKit SKU CDS984289O; 2) OPEN HEART CDSKit SKU CDS984355K; 3) BAG A OPEN HEART KITKit SKU DYKM1025D; 4) RR-CABG SUPPLEMENTAL PACKKit SKU DYNJ0394752
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1052-2026·2026-01-21
Medline IV Administration Kits Recalled Due to Check Valve Malfunction
Medline is recalling IV administration kits containing B. Braun administration sets because check valve components may become stuck in open or closed positions. Ninety-six units were distributed nationwide.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1063-2026·2026-01-21
Philips Allura Xper FD10F Medical Imaging System Electrical Short-Circuit Risk
Philips is recalling 12 Allura Xper FD10F angiography systems worldwide because the cooling system's drip tray may not be installed. Without the tray, coolant could contact electrical components and cause short-circuits leading to system shutdown.
Product
Allura Xper FD10F; Model Number: 722002;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1064-2026·2026-01-21
Allura Xper FD10 medical imaging system recalled for cooling drip tray issue
Philips recalls 93 Allura Xper FD10 imaging systems due to missing or undocumented drip tray installations, which could allow coolant to contact electrical components and cause system shutdown.
Product
Allura Xper FD10; Model Number: 722003;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1040-2026·2026-01-21
CT X-ray System Component Recalled for Missing Safety Label
Mobius Imaging is recalling 101 AIRO CT X-ray system pendant components lacking the required 'Safe Hand Position Warning' label, which informs operators of proper positioning during use.
Product
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1043-2026·2026-01-21
Vanta Clinician Programmer Application versions recalled for software malfunction
Medtronic recalls versions 2.0.2465 and 2.0.2683 of the Vanta Clinician Programmer Application. The software does not function as intended, creating potential for prolonged or postponed surgical procedures.
Product
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1079-2026·2026-01-21
Philips Azurion X-ray Systems software defect may cause imaging loss and system failures
Philips Azurion X-ray imaging systems may experience nine software issues causing loss of X-ray imaging, system restarts, and diagnostic tool misalignment. 990 units distributed worldwide are affected.
Product
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1055-2026·2026-01-21
Medline IV Administration Kits Recalled for Check Valve Malfunction
Medline has recalled multiple kits containing B. Braun IV administration sets because the check valve components may become stuck in open or closed positions. The recall affects 3,045 units distributed nationwide.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DRAWER 2 IV SUPPLIES, Medline kit SKU ACC010271B; 2) DRAWER 2 IV FLUIDS & TUBING, Medline kit SKU ACC010416B; 3) OXYGENATION & TUBING TRAY, Medline kit SKU ACC010525C; 4)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1024-2026·2026-01-21
Measurement Spectrometer Laser Safety Defect from Cable Failure
The MAVERICK Measurement Module Spectrometer has a cable defect that can cause elevated laser output (approximately 1,600 mW) or unintended laser firing during measurement cycles. No injuries have been reported.
Product
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1051-2026·2026-01-21
Medline IV Administration Kits recalled for stuck check valve defect
Medline is recalling certain pre-op kits due to check valve defects in IV and pump administration sets. The valves may become stuck in either position, potentially impairing medication delivery.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) DELUXE PRE OP KIT, Medline SKU DYKS2034A; 2) DELUXE PRE OP KIT, Medline SKU DYKS2006B.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1100-2026·2026-01-21
Arterial blood sampling kits recalled for cracked syringe collars and leakage risk
ICU Medical is recalling certain Pulsator Arterial Blood Sampling Kits due to cracks in the syringe collar that may cause blood leakage or delayed delivery during arterial sampling.
Product
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1076-2026·2026-01-21
Philips imaging system missing cooling unit drip tray installation
Certain Philips Allura Xper FD20/10 imaging systems may lack a required drip tray beneath the cooling unit. If missing, coolant could contact electrical components and cause system shutdown.
Product
Allura Xper FD20/10; Model Number: 722029;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1045-2026·2026-01-21
Nuclear Medicine Imaging Systems: Risk of Detector Fall During Transport
GE HealthCare is recalling certain nuclear medicine imaging systems with potentially compromised detector mounting mechanisms that could fail during transport. No injuries have been reported, but detector falls could cause serious harm.
Product
SMV DSI, System, Tomography, Computed, Emission
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1041-2026·2026-01-21
AIRO CT Pendant Upgrade Missing Safe Hand Position Warning Label
Mobius Imaging is recalling 26 AIRO CT pendant upgrade components lacking a required 'Safe Hand Position Warning' label. The missing label could prevent users from recognizing safe hand positioning during equipment operation.
Product
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1018-2026·2026-01-21
MRI systems recalled for potential helium vessel rupture during emergency discharge
Canon Medical's VANTAGE TITAN 3T MRI systems may develop ice in the magnet vent system, which could trap helium gas and cause vessel rupture if an emergency discharge occurs, releasing pressurized helium into the scanning room.
Product
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1096-2026·2026-01-21
da Vinci SP Access Port Kit System Tray Cracks Risk Sterility Breach
Intuitive Surgical is recalling da Vinci SP Access Port Kits because the system tray may develop cracks that could breach sterility during surgical use.
Product
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1054-2026·2026-01-21
Medline IV Administration Kits Recalled for Stuck Check Valve Components
Medline kits containing B. Braun IV Administration Sets are recalled because check valve components may become stuck, potentially affecting medication delivery. Lot Number 25HBQ850 is affected.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: DR HOLCOMB FACIAL PACK, Medline kit SKU DYNJ54488A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1039-2026·2026-01-21
Medicrea Orthopedic Rotation Tool Handle May Detach During Surgery
Medicrea is recalling IB3D PL Instruments Sets because the orthopedic rotation tool handle may detach from the shaft, preventing implant rotation during surgery. The Class II recall affects 44 units distributed across nine U.S. states.
Product
Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1042-2026·2026-01-21
Boston Scientific Coyote Balloon Dilation Catheter Inflation Deflation Failure
Boston Scientific is recalling certain batches of Coyote Over-the-Wire Balloon Dilation Catheters that may not properly inflate or deflate during use in peripheral vessels.
Product
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210; Catheter, Angioplasty, Peripheral, Transluminal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1066-2026·2026-01-21
Philips medical imaging system may lack cooling unit drip tray
The Philips Allura Xper FD20 fluoroscopy system may lack a drip tray beneath its cooling unit, potentially allowing coolant to contact electrical components and cause device shutdown. The recall affects 143 units worldwide.
Product
Allura Xper FD20; Model Number: 722006;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1073-2026·2026-01-21
Philips Allura Xper FD10 medical imaging system drip tray installation issue
Philips is recalling the Allura Xper FD10 because the drip tray beneath the cooling unit may not be installed in some units, potentially allowing coolant to contact electrical components and cause system shutdown.
Product
Allura Xper FD10; Model Number: 722026;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1088-2026·2026-01-21
Medline Surgical Procedure Kits Recalled Due to Irrigation Solution Leakage
Medline is recalling 12,584 surgical procedure kits containing Stryker Strykeflow 2 irrigators due to a design defect that causes irrigation solution to leak and emit vaporized saline during use.
Product
Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1081-2026·2026-01-21
PALACOS R+G pro bone cement recalled for ampoule breakage defect
PALACOS R+G pro bone cement is recalled due to defects that prevent ampoule breakage, blocking cement dough formation and making the product unusable.
Product
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitabl
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1048-2026·2026-01-21
Fresenius Kabi Emphasizes LVP Programming Instructions in Ivenix Infusion System
Fresenius Kabi is emphasizing instructions for large volume parenteral (LVP) programming duration in the Ivenix Infusion System software. 30 units were distributed nationwide.
Product
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1062-2026·2026-01-21
Philips Allura Xper FD10C Medical Imaging Systems Cooling Drip Tray Installation Issue
Philips is recalling 38 Allura Xper FD10C medical imaging systems in which the cooling unit drip tray may not be properly installed, potentially allowing coolant to contact electrical components and cause system shutdown.
Product
Product Name: Allura Xper FD10C; Model number: 722001;
Category
Medical Device
Distribution
Distributed nationwide

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1176–1200 of 13381