FDA•MODERATE
STA Liatest Free Protein S
Diagnostica Stago is recalling STA Liatest Free Protein S kits due to the risk of inaccurate test results for normal patient plasma levels.
Filters
Category
Agency
Severity
All Recalls
Back to home ←
FDA•MODERATEReact Health PHOENIX 5L Oxygen ConcentratorReact Health PHOENIX 5L Oxygen Concentrator recalled due to devices not meeting quality specifications.
FDA•MODERATEIvenix Infusion System Large Volume PumpFresenius Kabi is recalling the Ivenix Infusion System LVP due to a risk of the cassette loading lever breaking during use.
FDA•MODERATEPure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep ResetPure Solutions recalling 1 fl oz sleep formula bottles due to undeclared milk allergen from bovine colostrum.
FDA•MODERATECoco's Italian Market Cannoli Making KitCoco's Italian Market is recalling its 8 oz. Cannoli Making Kit due to undeclared wheat and milk allergens.
2 products
FDA•LOWPitavastatin Tablets, 2 mgNorthstar Rx LLC is recalling Pitavastatin Tablets, 2 mg (NDC 72603-479-01) due to a foreign 1 mg tablet found in bottles.
FDA•MODERATEEquinoxe Ergo Modular Impactor HandleExactech is recalling the Equinoxe Ergo Modular Impactor Handle due to a missing cross-pin that may cause device failure.
2 products
FDA•MODERATEImactis CT-Navigation SystemGE Medical Systems is recalling Imactis CT-Navigation System (Models E85101LA, E85101LP) due to potential needle trajectory/tip position discordance.
FDA•MODERATEIBA Proton Therapy System PROTEUS 235IBA PROTEUS 235 proton therapy systems may fail to stop beam delivery if external gating device signal is lost, risking patient mistreatment.
FDA•MODERATEPro Numb Tattoo Numbing SprayPro Numb is recalling 5% Lidocaine Tattoo Numbing Spray due to cGMP manufacturing deviations.
2 products
FDA•MODERATEB. Braun Winged Infusion SetsB. Braun is recalling 21GA Winged Infusion Sets (Model 7M2802) due to the risk of needle tips being dull, blunt, or breaking during use.
3 products
FDA•MODERATEMICS3 Angled Sagittal Saw AttachmentHowmedica Osteonics is recalling the MICS3 Angled Sagittal Saw Attachment because external screws may loosen and detach during use.
FDA•MODERATEOn-X Mitral Heart Valve with Conform-X Sewing RingOn-X is recalling Model ONXMC-25/33 Mitral Heart Valve due to incomplete testing before distribution.
FDA•MODERATETiki Bar Dark Chocolatey Peanut Butter & PretzelTiki Bar Dark Chocolatey Peanut Butter & Pretzel is recalled due to an undeclared peanut allergen.
FDA•MODERATEBeckman Coulter Chemistry AnalyzersBeckman Coulter is recalling chemistry analyzers due to a software error that may cause system delays and impact patient diagnosis.
2 products
FDA•MODERATEMedline Cardiac Procedure KitsMedline is recalling cardiac procedure kits to clarify that the included chest drainage units are intended for adult patients only.
FDA•MODERATEMiniMed 780G Insulin PumpMedtronic is recalling MiniMed 780G insulin pumps (software 6.60-6.62) due to software defects that may cause inaccurate insulin delivery.
- Device RecallFDA•MODERATECentricity Universal Viewer Software
GE is recalling Centricity Universal Viewer software versions 5.0 and 7.0 due to a cybersecurity vulnerability that may expose user credentials.
4 products - Device RecallFDA•MODERATEHealthCast Vital Sync Remote Patient Monitoring System
Covidien is recalling Vital Sync software because bedside monitor alarms may fail to transmit to the remote monitoring system.
2 products 
FDA•MODERATETandem Insulin Infusion PumpTandem is recalling insulin infusion pumps in Czech Republic and Slovakia due to user guide translation errors that could cause unintended insulin delivery.
FDA•MODERATEPreema Bright Red and Orange Food Colour PowderPreema Bright Red and Orange Food Colour Powder recalled for banned carmoisine and undeclared FD&C Yellow 5 and Red 40.
2 products
FDA•MODERATEMetoprolol Succinate Extended-Release TabletsTeva is recalling Metoprolol Succinate Extended-Release Tablets due to failed dissolution specifications.
4 products
FDA•MODERATEOlympus Single Use Biopsy ValveOlympus is recalling the MAJ-210 single use biopsy valve due to the risk of rubber fragments detaching during use.
2 products
FDA•MODERATEParadise Ultrasound Renal Denervation System CatheterReCor Medical is recalling Paradise Ultrasound Renal Denervation System catheters that were intended to be scrapped and are not for use.
3 products- Device RecallFDA•MODERATEB. Braun Cesk Northside Anesthesia Tray
B. Braun is recalling the Cesk Northside Anesthesia Tray (Model 555076) due to potential cracking of the included adhesive tubing.
8 products 
FDA•MODERATEJiffy Original Composite Polisher Cups (Coarse)Ultradent is recalling Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011, due to crumbling and breakage risk.
FDA•MODERATEMedline Medcrest Surgical GownsMedline is recalling Medcrest surgical gowns due to fabric delamination risks that may lead to infection or delays in patient care.
3 products
FDA•MODERATEFrozen Half Shell OystersKhee Trading is recalling frozen half shell oysters due to potential Norovirus contamination.
FDA•MODERATEDiclofenac Sodium Topical Gel 3%Taro Pharmaceuticals is recalling Diclofenac Sodium Topical Gel 3% (100 g) due to viscosity specification failure.
FDA•MODERATEBD 10mL Non-Sterile Luer-Lok SyringeBD is recalling 10mL non-sterile Luer-Lok syringes (catalog 301029) due to incorrect Luer Slip syringes mixed into batches.
FDA•MODERATELutronic CLARITY II Laser SystemLutronic is recalling CLARITY II Laser System (Model 1110200210) due to sparking and burn hazard.
FDA•MODERATEKeto-C Antiseptic WipesStratford Care USA is recalling Keto-C Antiseptic Wipes (50ct) due to misbranding; product contains non-medicated otic flush instead of labeled antiseptic.
36 products
FDA•MODERATERepackaged M&Ms Peanut CandiesBeacon Promotions is recalling 1.3 oz repackaged M&Ms Peanut candies due to undeclared milk, soy, and peanut allergens.
3 products
FDA•MODERATEGerber Arrowroot BiscuitsGerber Arrowroot Biscuits (5.5 oz, UPC 015000005962) recalled for potential paper/plastic contamination in arrowroot flour.
FDA•MODERATEAsteria Health Testosterone Sterile PelletsAsteria Health is recalling 100 mg Testosterone sterile pellets due to the potential presence of metal particulate matter.
25 products
FDA•MODERATETrazodone Hydrochloride 50 mg TabletsGranules Pharmaceuticals is recalling Trazodone Hydrochloride 50 mg tablets (NDC 70010-231-01) due to foreign tablets or capsules in bottles.
FDA•MODERATESodium Iodide (I-131) Therapeutic Oral SolutionRadnostix is recalling Sodium Iodide (I-131) Therapeutic Oral Solution due to the presence of particulate matter.
FDA•MODERATEPhilips Azurion Image Guided Therapy SystemPhilips is recalling Azurion 3 and 7 M12 systems over a software defect that can cause unexpected patient table movement.
8 products
FDA•MODERATETops GOLD PicklesMangalm is recalling Tops GOLD pickle products due to potential erucic acid contamination from mustard oil.
6 products
FDA•MODERATEI.T.S. Headless Compression Screw SystemI.T.S. is recalling the Headless Compression Screw System due to higher-than-expected temperature increases during MRI procedures.
24 products
FDA•MODERATEDatascope CS300 IABPDatascope is updating the IFU for CS300 IABP software version C.01 to correct battery runtime and cycle specifications.
2 products
FDA•MODERATERed Button Movie House PopcornRed Button Movie House Popcorn is being recalled due to the potential presence of foreign material.
FDA•MODERATEBisoprolol Fumarate and Hydrochlorothiazide Tablets 2.5 mg/6.25 mgUnichem Pharmaceuticals recalls Bisoprolol/Hydrochlorothiazide 2.5/6.25 mg tablets (NDC 29300-187-01) due to N-Nitroso Bisoprolol impurity specification failure.
FDA•LOWDoxazosin Tablets, USP 4 mgUnichem is recalling Doxazosin Tablets 4 mg (NDC 29300-353-10) due to incorrect tablet imprinting that may cause medication errors.
FDA•MODERATEAuris Health MONARCH Platform Bronchoscopy SystemAuris Health is recalling MONARCH Platform Bronchoscopy systems due to a software issue that may cause unexpected robotic arm repositioning and contact with the patient.
FDA•MODERATEEVO+ Visian Toric Implantable Collamer Lens (TICL)Staar Surgical is recalling EVO+ Visian Toric ICL Model VTICM5 due to incorrect length labeling (12.1 mm labeled vs. 12.6 mm actual) causing excessive vault and potential angle closure.
FDA•MODERATEPhysio-Control Infant/Child Defibrillator ElectrodesPhysio-Control is recalling infant/child defibrillator electrodes due to a risk of delamination that may prevent proper therapy delivery.
2 products
FDA•MODERATEMOLLI 2 Surgical Marker SystemStryker is updating the MOLLI 2 System labeling due to the risk of magnetized surgical tools dislodging markers during tissue removal.
2 products
FDA•MODERATEAdapt Pump Model 61600200Agiliti is recalling Adapt Pump Model 61600200 due to Microclimate Management function failure after Autofirm use.
FDA•MODERATECrunchy Caramel Dark ChocolateGarcia Nevett is recalling Crunchy Caramel dark chocolate bars due to an undeclared milk allergen.