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FDA recalls

Food, drug, biologic, medical device and cosmetic recalls from the FDA, newest first. 1,957 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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16 recalls that day

GE Healthcare MAC VU360 Electrocardiographs

After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity.

Moderate risk, FDA, Software defect

Merge OrthoPACS and PACS

Thumbnails from a previously opened patient study may be displayed while a different patient study is open.

Moderate risk, FDA, Device defect

Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls

The Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls have too much sodium azide, which can cause mild skin or eye irritation.

Low risk, FDA, Quality testing problem

Syva Emit Disopyramide Assay Enzyme Immunoassay

The Syva Emit Disopyramide Assay has too much sodium azide in one lot, which can cause mild skin or eye irritation.

Low risk, FDA, Quality testing problem

Happiest Baby Pre-Loved SNOO Smart Sleeper

Refurbished bassinets failed to meet quality standards prior to distribution.

Moderate risk, FDA, Device defect

American Natl. Red Cross Apheresis Platelets, PAS, Leukocytes Reduced

Apheresis Platelets, PAS, Leukocytes Reduced, were collected on an instrument undergoing equipment qualification and without quality control testing.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

American National Red Cross Apheresis Platelets

Apheresis platelets labeled as leukocytes reduced failed a monthly residual white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Labeling error

10 recalls that day

Bettergoods Brand Pistachio Nut Butter

Pistachio Nut Butter may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

Maquet Critical Care Flow Anesthesia Machines

The Flow Anesthesia Machine may fail to deliver anesthetic agent when the vaporizer is activated.

Moderate risk, FDA, Device defect

Zimmer Biomet Intramedullary Bone Saw Blade Assembly

The Intramedullary Bone Saw Blade Assembly may have damaged sterile barrier packaging due to an exposed saw blade.

Moderate risk, FDA, Sterility problem

Stryker Ahto Tube Sets and Suction/Irrigator Packaging

Stryker Ahto Tube Sets and Suction/Irrigator Packaging can leak from the handpiece during use.

Moderate risk, FDA, Device defect

Medical Action Industries Dialysis Change Tray Clear Sequence

The Dialysis Change Tray Clear Sequence contains a needle free access device with an improper seal that may cause doming or tearing of the silicone seal.

Moderate risk, FDA, Device defect

OXOS Medical MC2 Portable X-Ray System

The MC2 Portable X-Ray System has a defective circuit board that overheats.

Moderate risk, FDA, Device defect

Innovasis Vector Pedicle Screw System Anti-Torque

The anti-torque instrument may have an undersized condition, preventing engagement with the pedicle screw tulip and rod during tightening.

Moderate risk, FDA, Device defect

Nuclein DASH Rapid PCR Instrument

The DASH Rapid PCR Instrument may show false co-infection results due to a software issue.

Moderate risk, FDA, Software defect

American Red Cross Blood Services Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were labeled as leukocytes reduced but were not tested to verify white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

American Red Cross Blood Svcs Red Blood Cells, Leukocytes Reduced

Red Blood Cells and Apheresis Red Blood Cells were collected from donors who reported travel to a malaria endemic area but were not assessed for residency.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

12 recalls that day

Adequan Canine and Equine Injections

Adequan i.m. and Adequan Canine injections contain glass fibers, which may cause injection site reactions.

Moderate risk, FDA, Contamination

Optiray Imaging Bulk Package-350, Ioversol Injection 74%

Optiray Imaging Bulk Package-350 contains particulate matter including plastic, stainless steel, and glass, which may cause local irritation or swelling.

High risk, FDA, Foreign object

Parnell Techologies Sevoflurane Inhalation Anesthetic for Dogs

Sevoflurane inhalation solution has a bottle collar notch pattern incompatible with the sevoflurane-specific anti-spill pour spout.

Not yet rated, FDA

Halyard Cardiac Catheterization and Angiography Kits

The kits contain manifolds with particulates in the fluid path.

High risk, FDA, Foreign object

Munevo DRIVE and Munevo DRIVE R-Net Powered Wheelchair Hands-Free Control Application

A software issue may cause the wheelchair's driving mechanism to fall out of calibration, leading to unexpected steering drift or imprecise control.

Moderate risk, FDA, Software defect

THERANICA BIOELECTRONICS Nerivio Infinity

Nerivio Infinity may have a thermal-runway event during charging, causing smoke and odor.

Moderate risk, FDA, Device defect

Copan WASPLab Automated Culture Plate Incubators and Imagers

WASPLab has a software issue that may prevent users from overwriting results.

Moderate risk, FDA, Software defect

Boston Scientific Radial Jaw 4 Biopsy Forceps

Boston Scientific Radial Jaw 4 Biopsy Forceps may have a breach in the sterile barrier of their packaging.

Moderate risk, FDA, Sterility problem

FORWARD Oral Airway Kit and Kingfisher Compact Individual First Aid Kit

The device could potentially contain an occluded or partially occluded Guedel Airway tip.

Moderate risk, FDA, Device defect

Quantum Rehab Power Wheelchairs

Quantum Rehab powered wheelchairs may show reminder pop-ups while in use, causing unexpected stops or crashes.

Moderate risk, FDA, Device defect

Charger for the Therabody Theragun, G4 PRO Massage Device

The charger for the Theragun G4 Pro may overheat, posing a fire risk.

Moderate risk, FDA, Device defect

Normand Info REMISOL Advance Data Manager

Remisol Advance with Software Version 2.5 may replace a final combo test result with a sub-result, causing incorrect reporting.

Moderate risk, FDA, Software defect

4 recalls that day

Bard Access Systems BD Needle Kit for Powered Driver

BD Needle Kit for Powered Driver may have difficulty removing the obturator, potentially causing delayed therapy.

High risk, FDA, Device defect

Ukrop's Homestyle Foods Bread Pudding with Vanilla Sauce

Bread Pudding with Vanilla Sauce may contain metal fragments, which could cause injury.

Moderate risk, FDA, Foreign object

Terex Utilities Power Over Fiber Base Module

The Power Over Fiber Base Module is not certified and is improperly labeled.

Moderate risk, FDA, Unapproved product

Medical Action Industries Medline Angiographic Manifold Packs

Cardiovascular procedure kits contain manifolds that may have particulate within the fluid path.

High risk, FDA, Foreign object

4 recalls that day

529 Commerce Aquafaba Powder Vegan Replacement

Aquafaba Powder may contain undeclared egg, posing a risk of serious allergic reactions.

High risk, FDA, Undeclared egg

Publix Super Markets: Blueberries and Mixed Berries

GreenWise Organic Whole Blueberries and Whole Mixed Berries may be contaminated with E. coli O145, which can cause severe stomach cramps and diarrhea.

High risk, FDA, Ended, E. coli

Stryker Hoffmann II Connecting Rod Micro

Stryker Hoffmann II Connecting Rod Micro may crack following cleaning and sterilization.

Moderate risk, FDA, Device defect

Instrumentation Laboratory GEM Premier 5000 and GEM Premier 7000 Blood Analyzers

GEM Premier blood analyzers with BCR wands may assign patient results to the wrong patient ID, potentially leading to inappropriate clinical management.

Moderate risk, FDA, Device defect

5 recalls that day

Glenmark Azelaic Acid Gel

Azelaic Acid Gel, 15% has an abnormal texture or consistency, described as grainy, gritty, or sandy.

Moderate risk, FDA, Manufacturing problem

Mellish Island Super Skin Dietary Supplement

Mellish Island Super Skin dietary supplement does not declare the source of marine collagen, which is fish.

Moderate risk, FDA, Undeclared fish

SeaSpine OsteoBallast and Ballast Bone Grafts

The products were filled with approximately 4.5 cc of demineralized bone matrix instead of approximately 7.5 cc.

Moderate risk, FDA, Device defect

ResMed Astral 100 and 150 Ventilators

The Resmed Astral ventilator system can fail due to electrolyte leakage, interrupting ventilation therapy.

High risk, FDA, Device defect

Galliker Dairy DQ Chocolate Ice Cream Mix

DQ Chocolate Reduced Fat Ice Cream Mix contains metal shavings.

Moderate risk, FDA, Ended, Foreign object

5 recalls that day

Fundamental Feed Equine Forage Pellets

Forage pellets for horses have elevated aflatoxin levels.

High risk, FDA, Ended, Chemical contamination

EXO Black Tattoo Ink

EXO Black tattoo ink tested positive for pathogenic bacteria Pseudomonas aeruginosa.

Moderate risk, FDA, Contamination

Philips CT Scanners

The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually.

Moderate risk, FDA, Device defect

AMS Aligned Medical Solutions Medical Convenience Kits

AMS medical convenience kits contain Elevaris Lidocaine HCl injection USP with supplier quality issues.

Moderate risk, FDA, Packaging defect

Medtronic Perfusion Systems EOPA Arterial Cannulas

EOPA arterial cannulae may have pinhole leaks in the wire-wound body during cardiopulmonary bypass.

Moderate risk, FDA, Device defect

15 recalls that day

Long Grove Pharmaceuticals Cyclophosphamide for Injection

Cyclophosphamide for Injection contains stainless steel particulate matter that can cause serious adverse events, including death.

High risk, FDA, Foreign object

Baxter Cefazolin in Dextrose Injection

Cefazolin in Dextrose Injection may contain particulate matter, which can cause pulmonary emboli, blood vessel occlusions, and phlebitis.

High risk, FDA, Foreign object

American Regent Nitroglycerin, Cyanocobalamin, Aminocaproic Acid, Atropine Sulfate, Acetylcysteine, Selenious Acid, Multrys, Papaverine HCl, Tralement and Nicardipine Injections

American Regent injections contain particulate matter.

High risk, FDA, Contamination