Silastic Foley Catheters
Silastic Foley Catheters have a stain on their surface.
Device defect recalls
Recalls flagged for device defect, newest first. 384 recalls
3 recalls
1 recall
OneLIF Interbody Cage
The OneLIF Interbody Cage's inserter may fail to attach, causing procedural delays.
1 recall
ICU Medical ChemoLock Oncology Kits and Transfer Sets
Oncology sets may leak, causing therapy interruption and possible exposure to hazardous substances.
2 recalls
Tangent Endoscopy Single Use Digital Catheter
The Tangent Single Use Digital Catheter can fracture at the distal shaft tip.
Swan-Ganz Catheter
Swan-Ganz Catheters may leak or break at the blue proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
3 products
1 recall
LVIS Intraluminal Support Device
The LVIS Intraluminal Support Device may have dimensional nonconformance or incorrect configuration, potentially causing vessel injury or incomplete expansion.
1 recall
Arrow Hemodialysis Catheters
Arrow Edge Hemodialysis Catheterization Product may not split as intended, causing withdrawal resistance, pain, bleeding, and tissue injury.
4 products
5 recalls
ZYMUTEST HIA IgG, in Vitro Diagnostic ELISA Kit
The ZYMUTEST HIA IgG kit may have incorrect values for the positive control.
Philips Azurion
Philips Azurion has bolts and plastic parts that may loosen or break.
QuickVue Dipstick Strep A Test
Reason given by FDA: Product has the potential for false positive results.
Thermedx FluidSmart Urology Tube Set
Due to nonconforming products being inadvertently distributed.
Hologic Selenia Dimensions and 3Dimensions Mammography Systems
Selenia Dimensions Mammography Systems can develop loose, missing, or broken internal bolts over time.
2 products
1 recall
Jolife LUCAS Chest Compression System
LUCAS chest compression systems may have service records that do not justify passing results.
2 recalls
Donjoy IceMan CLASSIC3 Cold Therapy Unit
The IceMan CLASSIC3 cold therapy unit has a broken connector that may interrupt prescribed cold therapy.
4 products
On-X Mitral Heart Valve with Conform-X Sewing Ring
The heart valve was released before all required testing was complete, so it may not meet release specifications.
1 recall
BioCera Fibers and ZENBONE
BioCera Fibers bone void filler falls outside standard specifications.
2 products
5 recalls
Mint Lesion
If the connection between a Mint Lesion workstation and the server is interrupted while performing a read, some information may be lost or incorrectly linked to other patients.
Medline Namic Angiographic Control Syringes Convenience Kits
Convenience kits containing syringes with a rotating adaptor may unwind during use, causing loose or full disconnection.
Biofire Spotfire Respiratory/Sore Throat Panel
The respiratory/sore throat panel test may result in false negative results and control failures.
Medical Action Industries Pack Cath BHH
Pack Cath BHH contains a syringe whose rotating adapter may unwind, causing loose or full disconnection.
DEX Ophthalmic Tissue Forceps
DEX Ophthalmic Tissue Forceps have a field safety corrective action for their instructions for use.
12 products
1 recall
Physio-Control LIFEPAK 15
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.
6 recalls
AVID Medical Halyard Cardiac Cath and Cath Lab Kits
Halyard cardiac cath packs and kits may have a syringe adaptor that can unwind, causing loose or full disconnection.
10 products
Cook Centimeter Sizing Catheters
Marker bands may be at an increased risk of cracking/breakage.
3 products
Erbe ERBEFLO CleverCap CO2 Tubing and Cap Sets
The Erbeflo CleverCap CO2 Hybrid CO2 Tubing/Cap Set may allow unintended water flow, leading to water aspiration and respiratory failure.
3 products
Da Vinci X, Xi Surgical System
The da Vinci X and Xi surgical systems have screws in the arm that may break.
VOCSN V+Pro Package
The VOCSN V+Pro respiratory system may leak oxygen, reducing oxygen delivery and increasing fire risk.
Intuitive 8 mm SureForm 30 Gray Reloads
The reloads may potentially produce an incomplete staple line.
6 recalls
Siemens Epoc BGEM BUN Test Cards
The affected product can result in discrepant low pH and measured Total Carbon Dioxide results.
Straumann N!Ce Full-Arch Restorations
Straumann n!ce PMMA Full-arch Restoration has an incorrect screw seat interface.
2 products
Becton Dickinson BD GasPak EZ CO2 and Campy Pouch Systems
BD GasPak EZ CO2 Pouch System may produce carbon dioxide levels below specification.
2 products
Merit Medical Systems Philips Bridge Prep Kit
Philips Bridge Prep Kit may experience resistance when advanced over a guidewire.
4 products
Leksell Vantage Arc System
The Leksell Vantage Arc System has locking mechanisms that may not secure properly, causing coordinate shifting.
Heraeus PALAMIX Duo and Uno
The PALAMIX uno mixing rod may come loose during mixing in units older than ̈1.5 years.
2 products
1 recall
Siemens Healthcare Diagnostics Dimension Creatinine Flex Reagent Cartridge
This imprecision may lead to erroneously decreased or increased creatinine patient results.
1 recall
HiResolution Bionic Ear System M Zn-Air Battery Pak
The M Zn-Air Battery Pak has a battery door that does not require a tool to replace the button/coin cell battery.
4 recalls
Medtronic Sphere-9 Catheter
The Sphere-9 Catheter can cause ventricular fibrillation during RF therapy in patients with certain Biotronik defibrillators.
Milestone Vacuum Bag SU Large Specimen Containers
The non-sterile specimen container may have reagent leakage.
Kiwi Omni Vacuum Delivery System
Due to complaints of device breakage at the traction force gauge to handle joint.
Genius Review Station Display (Barco Monitor)
The Genius Review Station Display can be operated outside its validated configuration due to user modifications.
6 recalls
Windstone Medical Packaging Custom Convenience Kits Pre Op Kits
Custom Convenience Kits Pre Op Kit - NS may allow backflow of medication from secondary IV containers into primary containers.
3 products
Micro-X Rover Mobile X-Ray System
The Rover Mobile X-ray System may malfunction, causing the X-ray to be inoperable.
Foundation Medicine FoundationOne CDx Sequencing Agent
Sequencing Agent SEQ0067 may increase phasing, potentially causing false-positive BARD1 splice site indel artifact variants.
Arrow International Catheters and Introducer Kits
Arrow International Catheters and Introducer Kits have liquid adhesive that was incorrectly manufactured.
8 products
Beckman Coulter Access Total T4 Calibrator
The Access Total T4 Calibrator shows a negative bias on DxI 600/800 instruments, with slopes outside specifications.
Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes
The OER-ELITE Endoscope Reprocessor Connecting Tubes may have lock levers that fail prematurely.
12 products
5 recalls
Uvlizer Ultraviolet-C Germicidal Wands
The handheld ultraviolet-C germicidal wand can expose nearby persons to UVC radiation above safety limits.
Uvlizer Handheld Ultraviolet-C Germicidal Wands
A handheld ultraviolet-C germicidal wand can expose nearby persons to UVC radiation above safety limits.
Medline Guidewires, Syringes and Kits
Medline Namic Guidewires, syringes, and kits have had regulatory clearances rescinded.
22 products
Olympus Thunderbeat II Shears w/Ultrasonic Mode
Olympus Thunderbeat II Shears w/Ultrasonic Mode may have a distal tip component that detaches during use.
4 products