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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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13 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

14 recalls that day

Gas-X Extra Strength Softgels

Gas-X Extra Strength Softgels may be contaminated with a diluted propylene glycol-based coolant, which could cause nausea, vomiting, abdominal pain.

High risk, FDA, Chemical contamination

Pearl Milling Company Original Pancake & Waffle Mix Complete

Pancake and waffle mix has undeclared milk and soy.

High risk, FDA, Ended, Undeclared milk

Up & Up Fragrance Free and Fresh Cucumber Scented Baby Wipes

Up & up Fragrance Free and Fresh Cucumber Scented Baby Wipes may be contaminated with Burkholderia, which can cause serious infections.

High risk, FDA, Contamination

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

The Coffee Connexion Cheese, Alfredo and Cream Sauces

Cheese sauce mixes and other sauces contain dry milk powder that may be contaminated with Salmonella.

High risk, FDA, Salmonella

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

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a donor screening deviation.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98846

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a screening deviation.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98845

LifeShare Blood Centers Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who lacked documentation of arm inspection.

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

Bloodworks Platelets Extended Dating

Platelets Extended Dating were distributed without a visual inspection.

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

13 recalls that day

Lannett Niacin Extended-Release Tablets

Lannett Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Guardian Drug Antacid Tablets

Guardian Drug Antacid Tablets contain small metallic particles.

Moderate risk, FDA, Foreign object

Forte BioPharma Xyvona (Levorphanol Tartrate Tablets)

Forte BioPharma Xyvona (levorphanol tartrate tablets) has labeling issues.

Moderate risk, FDA, Labeling error

Wilco Peanut Raw Shelled Peanuts

Raw Shelled Peanuts (Runner Type) have an undeclared tree nut allergen.

High risk, FDA, Undeclared tree nut

DeRoyal Covaderm Plus Vascular Access Dressings

Covaderm Plus, Vascular Access Dressing lacks sterility assurance.

Moderate risk, FDA, Sterility problem

Asclemed USA Duloxetine DR Capsules

Duloxetine DR Capsules contain a nitrosamine impurity above the acceptable intake limit.

Moderate risk, FDA, Drug impurity

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

American Red Cross Blood Services Blood Components

Red blood cells, plasma, and cryoprecipitated AHF may have been prepared with incorrect arm preparation.

Moderate risk, FDA, Ended, Hospital use

11 recalls that day

Prime Food Processing Dried Herring Fish

Dried Herring Fish was improperly eviscerated, which may result in C. botulinum (botulism) contamination.

High risk, FDA, Botulism

University of California Health Donor Human Milk

Standard and Pediatric Pasteurized Donor Human Milk may contain plastic particles.

Moderate risk, FDA, Ended, Contamination

Spectra Medical Devices Lidocaine HCl Injection

Lidocaine HCl Injection USP lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Lunds & Byerly's Curry Powder Sweet

Sesame Seeds White were labeled as Curry Powder Sweet.

Moderate risk, FDA, Labeling error

Albertsons: 121 products

Albertsons foods contain undeclared allergens.

Moderate risk, FDA, Ended, Undeclared tree nut

Sato Yunker Energy & Health Herbal Supplement with Vitamins

Yunker(branded) Energy & Health Herbal Supplement with Vitamins does not meet label claim for Vitamin E.

Low risk, FDA, Wrong nutrient levels

Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets

Amlodipine and Olmesartan Medoxomil Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Arvis Hip & Knee 2.0 and 3.0 Instrument Set

The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.

Moderate risk, FDA, Device defect

Shimadzu Digital Angiography and Radiography Systems

Digital Angiography Systems and a Digital Radiography System have electromagnetic contactors that may weld together.

Moderate risk, FDA, Device defect

Daavlin Phothera 200 Phototherapy Devices

Phothera 200 Phototherapy Devices have calibration certificates with reversed outputs.

Moderate risk, FDA, Device defect

Creative Compounds Betaine Anhydrous

Betaine Anhydrous may contain possible carbon steel foreign material.

Moderate risk, FDA, Ended, Foreign object

6 recalls that day

PhaseOne Antimicrobial Solution

PhaseOne Antimicrobial Solution has a corroded internal spring that may discolor the solution and add trace metals.

Moderate risk, FDA, Foreign object