Skip to main content

FDA medical device recalls

Medical device recalls from FDA, newest first. 876 recalls Each recall is dated by the day its recall page names (how recalls are dated).
Filters · 1Sort Newest
Agency
Risk level
Status
Date
Sold in

5 recalls that day

Mito Red Light Super Mobile

The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.

Moderate risk, FDA, Device defect

4 recalls that day

Philips MultiDiagnost Eleva and Allura Xper Systems

Philips MultiDiagnost Eleva and Allura Xper systems have a hand switch that may not release, causing loss of imaging or unintended radiation.

Moderate risk, FDA, Device defect

AMD Medicom Ritmed Neurological Sponges

The sponges may not consistently meet endotoxin specification for devices that contact cerebrospinal fluid.

Moderate risk, FDA, Contamination

DirectCHECK ACT-LR Whole Blood Quality Control, Level 2

The directCHECK ACT-LR whole blood quality control has labeling with an incorrect performance range.

Moderate risk, FDA, Labeling error

Smith & Nephew Trigen Proximal Straight Humeral Nail

The humeral nail is missing distal holes and may lead to revision surgery if implanted.

Moderate risk, FDA, Manufacturing problem

3 recalls that day

Medtronic O-Arm O2 Imaging System

The system's detector panel firmware has an anomaly that can cause image artifacts.

Moderate risk, FDA, Software defect

ALYON and HarmonyAIR A-Series Surgical Lighting System

The surgical lighting systems may have light intensity control buttons that detach.

Moderate risk, FDA, Device defect

HarmonyAIR A-Series Surgical Lighting System

The HarmonyAIR A-Series Surgical Lighting System has paint that can chip or peel on its light heads.

Moderate risk, FDA, Device defect

1 recall that day

Arrow International Vascular Access and Catheterization Kits

Arrow International Vascular Access and Catheterization Kits contain lidocaine, bupivacaine.

High risk, FDA, Sterility problem

2 recalls that day

Medline Convenience Kits

The butyrate tubing may crack during actuation and render the product unusable for application.

Moderate risk, FDA, Device defect

Automated Impella Controller (AIC)

The Automated Impella Controller has a potential software error when used with left ventricular Impella devices.

High risk, FDA, Software defect

8 recalls that day

Fresh Roast Systems ColorTrack

The ColorTrack instrument could allow human access to infrared laser light levels in excess of its safety classification.

Moderate risk, FDA, Device defect

Halyard Pain, Towel, Drape and Eye Bag Packs

Sealed pouches in these packs were distributed without validated sterilization.

Moderate risk, FDA, Sterility problem

MOSAIQ Oncology Information System

Mosaiq Oncology Information System software may fail to load an adapted baseline shift plan during treatment delivery when a communication error occurs.

Moderate risk, FDA, Software defect

Boston Scientific Orca Single Use Air/Water and Suction Valves

Orca Single Use Air/Water and Suction Valves have a higher than anticipated occurrence of the suction button sticking.

Moderate risk, FDA, Device defect

Merlin Patient Care System (PCS)

Software malfunction may occur during pacing capture threshold test of pacemaker, causing the programmer to not communicate the command to terminate the test.

Moderate risk, FDA, Software defect

Boston Scientific Neuromodulation Clik X Anchor

The Clik X Anchor may lack sterility assurance.

Moderate risk, FDA, Sterility problem

Boston Scientific CSK and TCN Electrodes

Reusable electrodes may not meet expected performance levels.

Moderate risk, FDA, Device defect

Fresenius Medical Care Holdings Bicarby Dialysate

Bicarby Dialysate has an error in its labeling of the GTIN, which may lead to unrecognized use of a potassium solution with a differing concentration.

Moderate risk, FDA, Labeling error

3 recalls that day

Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit

Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit contains an incorrect package insert.

Moderate risk, FDA, Device defect

DT MedTech Hintermann Series Talar Implant

The Hintermann Series Talar Implant, Left, Size 2 contains a right implant device in its packaging.

Moderate risk, FDA, Labeling error

Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC)

The Siemens Dimension Tacrolimus Flex Reagent Cartridge may show a positive bias in quality control and patient sample results.

Moderate risk, FDA, Device defect

3 recalls that day

Medartis APTUS Cannulated Compression Screws

Cannulated Compression Screws for bone fixation have an off-center cannulation.

Moderate risk, FDA, Device defect

EXENT Analyser

The EXENT Analyser may falsely detect or miss M-protein, and falsely elevate or decrease its concentration.

Moderate risk, FDA, Device defect

Sagemax Bioceramics NexxZr T Multi Dental Zirconia

NexxZr T Multi A3.5 W98-16mm dental discs may have a reduced or missing dentin layer, increasing fracture risk under stress.

Moderate risk, FDA, Device defect

1 recall that day

NeoSpan SuperElastic Compression Staple w/Instruments

The NeoSpan SuperElastic Compression Staple w/Instruments lacks the Magnetic Resonance Conditional Symbol on its packaging and labels.

Moderate risk, FDA, Labeling error

11 recalls that day

DigitalDiagnost C90 Flex/Value/Chest/ER

The DigitalDiagnost C90 Flex/Value/Chest/ER was delivered without a required Seismic kit, which can prevent damage during seismic events.

Moderate risk, FDA, Device defect

Micromed S.p.A. Natus SD LTM 64 PLUS EEG Amplifier/recorder

The SD LTM 64 Plus EEG amplifier may show a 1-second delay between channels, potentially leading to misinterpretation of results.

Moderate risk, FDA, Software defect

CGuard Prime Carotid Stent System

The CGuard Prime Carotid Stent System may have deployment complications, causing high resistance or inability to deploy.

Moderate risk, FDA, Device defect

CORFLO and MIC Safety PEG Kits

Corflo and MIC Safety PEG kits contain lidocaine hydrochloride injection that was recalled for quality issues.

Moderate risk, FDA, Sterility problem

Mahurkar Elite PASS Trays

Mahurkar Elite PASS Trays are missing a specified dressing from certain lots.

Moderate risk, FDA, Labeling error

Allia Angiographic X-Ray System

A potential issue affects an electrical cable on certain IGS systems.

Moderate risk, FDA, Device defect

Fresenius Medical Care Bicarby Dialysate

Bicarby" Dialysate can leak during preparation, posing a slip and fall hazard.

Moderate risk, FDA, Device defect

Plum Duo Infusion, Duo Precision IV, and Solo Precision IV Pump

Under certain conditions, the pump may not display a soft limit alert.

Moderate risk, FDA, Device defect

D.O.R.C. TDC VELOCE Two Dimensional Cutters

The TDC Veloce Two Dimensional Cutter has a loose outer knife that can become loose during use.

Moderate risk, FDA, Device defect

EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves

Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures.

Moderate risk, FDA, Labeling error

Sporetraq Mail-In Spore Testing Service

The SporeTraq Mail-In Spore Testing Service was processed with an incorrect incubation process.

Moderate risk, FDA, Processing problem

6 recalls that day

Siemens Artis Pheno and Artis Icono Interventional Fluoroscopic X-Ray Systems

ARTIS pheno and ARTIS Icono interventional fluoroscopic x-ray systems may display a 0 x-ray dose while actually applying one.

Moderate risk, FDA, Device defect

Draeger Atlan A350 and A350XL Anesthesia Workstations

The Atlan anesthesia workstations either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.

High risk, FDA, Device defect

SSC- Surgical Specialties Sharpoint Microsurgical Knife

3.0mm surgical knives labeled and packaged as 2.2mm surgical knives.

Moderate risk, FDA, Labeling error

KayserBett IDA Pediatric Care Bed

The pediatric care bed can trap children under or between the bed frame and floor if hand control is not locked, risking serious injury or death.

High risk, FDA, Device defect

Grace Medical Stapes Prosthesis

The titanium/fluoroplastic piston has incorrect functional length on its labeling.

Moderate risk, FDA, Labeling error

Da Vinci 5

The Da Vinci 5 system tower has a near infrared handheld camera that may activate unintentionally when turning off illumination.

Moderate risk, FDA, Device defect

7 recalls that day

DeRoyal Covaderm Plus Vascular Access Dressings

Covaderm Plus, Vascular Access Dressing lacks sterility assurance.

Moderate risk, FDA, Sterility problem

Aligned Medical Fluids Kit

Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.

Moderate risk, FDA, Device defect

Fresenius Kabi Ivenix Infusion System LVP Software

The LVP software of the Ivenix Infusion System can report a false battery-health value and trigger a battery-depletion alarm.

High risk, FDA, Software defect

GE MAC 5 Resting ECG Analysis Systems

Software in development was made available for customer use.

Moderate risk, FDA, Software defect

CareFusion 303 BD Pyxis Medication Cabinets

BD Pyxis medication cabinets have a fingerprint scanner that may overheat and cause first-degree burns.

Moderate risk, FDA, Device defect

Bayer Avanta Multi-Patient Administration Tube Sets

Avanta Multi-Patient Administration Tube Sets have a fit issue that can cause the stopcock to disengage during contrast injection, interrupting the procedure.

Moderate risk, FDA, Device defect

B Braun Spinal Needle Procedure Kits

B Braun Spinal Needle Procedure Kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP, with potential quality issues.

High risk, FDA, Device defect