Medical device recalls

FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.

1226–1250 of 13399

HighFDA (Devices)·Z-1035-2026·2026-01-14
Medline oxygen masks recalled due to tubing disconnection risk
Medline Hudson RCI oxygen masks may experience tubing disconnection during use, potentially delaying patient care and causing hypoxia. The company has received multiple complaints about this defect.
Product
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRAT
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1025-2026·2026-01-14
Beckman Coulter Analyzer May Fail to Restart After Shutdown
Beckman Coulter's UniCel DxL 600 analyzer may fail to restart after shutdown due to a communication issue, preventing sample processing and causing delayed results. 1,272 units recalled worldwide.
Product
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0998-2026·2026-01-14
AlignRT InBore Medical Device Recalls Due to Incomplete Laser Instructions
Vision RT is recalling AlignRT InBore systems due to missing laser information in the Instructions for Use. The omission violates FDA regulatory requirements for laser safety documentation.
Product
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1026-2026·2026-01-14
Medical Analyzer May Fail to Restart After Shutdown, Delaying Patient Results
Beckman Coulter UniCel Dxl 800 analyzers may fail to restart following standard shutdown due to a communication issue. When this occurs, units cannot process patient samples, resulting in delayed test results.
Product
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1030-2026·2026-01-14
Impella 5.5 Cardiac Assist Devices Recalled for Incorrect Outer Box Packaging
Abiomed is recalling six Impella 5.5 with SmartAssist S2 cardiac assist devices distributed to Australia and Taiwan because they were packaged in an incorrect outer box carton.
Product
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Category
Medical Device
Distribution
0 states
HighCPSC·26165·2026-01-08
Agrish Adult Portable Bed Rails Recalled Due to Entrapment and Asphyxiation Risk
Agrish Adult Portable Bed Rails (about 5,000 units) are recalled for entrapment and asphyxiation risk. When attached to beds, users can become trapped within the rail or between the rail and mattress. Contact Agrish Direct for a refund.
Product
Agrish Adult Portable Bed Rails
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1007-2026·2026-01-07
Philips EPIQ Ultrasound Systems may unexpectedly reboot during use
Philips is recalling EPIQ Ultrasound Systems that may experience unexpected automatic reboots, potentially causing transducer damage. Users should contact Philips for resolution.
Product
Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF: , , 795200, 795201, 795231, 795232, 795234 REF: 795117, 795122
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1008-2026·2026-01-07
BVI Leos Laser Endoscopy System Recall: Missing USB Cable Ferrites
The BVI Leos Laser and Endoscopy System is being recalled because ferrites were omitted from the USB cable assembly, potentially causing electromagnetic interference. Five units were distributed in Florida, Michigan, Oklahoma, Texas, and Wisconsin.
Product
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0888-2026·2026-01-07
Material Processing Laser Products Recalled for Missing Remote Interlock Connector
SHENZHEN ATOMSTACK TECHNOLOGIES is recalling material processing laser products that lack a required remote interlock connector mandated by federal safety regulations. The missing component is required under 21 CFR 1040.10(f)(3).
Product
Material Processing Laser Products
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1006-2026·2026-01-07
Ultrasound probe covers recalled due to contamination defect risk
Sheathes3D ultrasound probe covers may have product defects allowing contamination during use, creating infection risk. Affected devices distributed nationwide in Washington state.
Product
Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm Tapered to 7.4cm x 30cm), Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Tapered, Rolled, Extra-Long, Individually Wrapped, Box of 50 Item Number 76339,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1004-2026·2026-01-07
Vortex Surgical Laser Probe Recalled Due to Insertion Defect
Vortex Surgical is recalling 221 units of its 25ga Illuminated Flex-Tip Laser Probe (Lot 2509040) because some units do not insert smoothly through a 25ga cannula.
Product
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1005-2026·2026-01-07
Mastisol Liquid Adhesive Recalled for Cracking Tubes During Use
Mastisol Liquid Adhesive vials with lot code 24161B are being recalled because the butyrate tube cracks during actuation, rendering the product unusable. Units distributed in the US and UK.
Product
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0996-2026·2025-12-31
Restore Clinician Programmer App reset message may prevent therapy resumption
A software issue in the Restore Clinician Programmer Application can prevent therapy from resuming, causing pain recurrence. Affected devices worldwide may require surgical replacement.
Product
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E P
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0933-2026·2025-12-31
Draeger Vapor 2000 anesthetic vaporizers recalled for component impurities
Draeger is recalling 431 Vapor 2000 anesthetic vaporizers with a component not manufactured to specification and containing impurities. The devices were distributed worldwide. No illnesses or injuries have been reported.
Product
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0939-2026·2025-12-31
Alcon Custom Pak ophthalmic surgical procedure packs recalled for incomplete seals
Alcon Custom Pak sterile ophthalmic surgical procedure packs may have incomplete seals compromising sterility. Affected units distributed in California, North Dakota, and Utah.
Product
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon Custom Paks are customer-designed sterile surgical procedure packs / convenience k
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0934-2026·2025-12-31
Draeger Vapor 3000 anesthetic vaporizer recalled due to out-of-specification component impurities
Draeger is recalling 188 Vapor 3000 anesthetic vaporizers worldwide because a component was manufactured outside specification with impurities that could affect anesthetic delivery.
Product
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0970-2026·2025-12-31
Affixus Femoral Nails recalled for potential implant fatigue fracture
Zimmer is recalling Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fatigue fracture and require surgery.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0965-2026·2025-12-31
Infusion pump software feature failure may prevent review of medication library changes
ICU Medical's LifeShield Drug Library Management v2.2.1 has a nonfunctional Change Summary review feature for certain migrated customers. Users must use alternate methods to review library changes, or risk over-delivery, under-delivery, or setup delays.
Product
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0963-2026·2025-12-31
Stryker CranialMask Tracker software error prevents surgical activation
The Stryker CranialMask Tracker may display a software error during surgery that prevents device activation. This surgical tracking device is used in cranial procedures.
Product
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positio
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0975-2026·2025-12-31
Zimmer Affixus Femoral Nails recalled for potential implant fracture risk
Zimmer is recalling Affixus Antegrade Femoral Nails due to undersized distal diameter that could cause implant fracture, potentially leading to tissue damage requiring surgery. The recall affects 23 units distributed nationwide.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0992-2026·2025-12-31
Diasol Dialysis Acid Concentrate Recalled for Safety and Efficacy Concerns
Diasol, Inc. is recalling its bicarbonate dialysis acid concentrate (Lot PHV08042) because the safety and efficacy of the product cannot be assured. Approximately 2,200 gallons were distributed nationwide.
Product
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0989-2026·2025-12-31
Diasol dialysis acid concentrate recalled due to safety and efficacy concerns
Diasol, Inc is recalling its bicarbonate dialysis acid concentrate (4,400 gallons) distributed nationwide due to safety and efficacy assurance issues.
Product
Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0964-2026·2025-12-31
Surgical Robot Console Motor Connector Failure May Lock Ergonomic Controls
Intuitive Surgical is recalling 144 da Vinci 5 Surgeon Console Column Motor Connectors due to potential connector failure that may lock ergonomic controls, preventing adjustment of headrest, armrest, viewer, and pedal tray until the device is restarted.
Product
da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Number: 380730-40
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0968-2026·2025-12-31
Affixus Femoral Nails Recalled for Potential Implant Fatigue Fracture Risk
Zimmer is recalling Affixus Antegrade Femoral Nails with undersized distal diameter risking implant fatigue fracture. Affected implants distributed across 14 US states could cause adverse tissue reactions, non-union, or require surgical intervention.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0974-2026·2025-12-31
Affixus Antegrade Femoral Nails Recalled for Potential Implant Fracture
Zimmer is recalling 11 Affixus Antegrade Femoral Nails due to potential undersized distal diameters that may cause implant fatigue fracture. Complications can include adverse tissue reaction, pain, non-union, or tissue damage requiring surgery.
Product
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A
Category
Medical Device
Distribution
Distributed nationwide

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