FDA•MODERATE
Olympus Thunderbeat II Shears
Olympus is recalling Thunderbeat II Shears (Model TB2-0520FC) due to the risk of a distal tip component detaching during use.
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All Recalls
Back to home ←- Device RecallFDA•MODERATEGenius Digital Diagnostics System Review Station Display
Hologic is correcting Genius Review Station displays due to unauthorized configuration changes that deviate from validated settings.
FDA•MODERATEHiResolution Bionic Ear System M Zn-Air Battery PakAdvanced Bionics is recalling M Zn-Air Battery Paks for sound processors due to a non-compliant battery door design.
2 products
FDA•MODERATETangent Single Use Digital CatheterTangent Endoscopy is recalling single-use digital catheters due to potential fractures at the distal shaft tip.
FDA•MODERATEVancomycin HCl InjectionFagron is recalling Vancomycin HCl 1.5g/250mL injections distributed nationwide due to sterility concerns and potential port detachment.
5 products
FDA•MODERATEExchange Select Honey Lemon Cough DropsExchange Select Honey Lemon Cough Drops are being recalled due to manufacturing quality concerns.
15 products
FDA•MODERATEFurosemide Tablets, USP 80 mgLeading Pharma is recalling Furosemide Tablets 80 mg (NDC 69315-118-01) due to N-nitroso-Furosemide above recommended limits.
FDA•MODERATEFoundationOne CDx Sequencing Agent SEQ0067Foundation Medicine is recalling Sequencing Agent SEQ0067 component of FoundationOne CDx due to possible false-positive BARD1 variants.
FDA•MODERATEProdisc C SK U.S. Cervical Disc ImplantCentinel Spine is recalling Prodisc C SK U.S. cervical disc implants due to a labeling mix-up between 5mm and 6mm sizes.
2 products
FDA•MODERATERiverence Smoked Trout DipRiverence is recalling Smoked Trout Dip due to an undeclared milk allergen.
FDA•MODERATETramadol Hydrochloride Tablets, USP 50 mgAmneal is recalling tramadol 50 mg tablets (NDC 60219-2348-5) due to elevated N-nitroso-desmethyl-tramadol impurity.
FDA•MODERATEClonidine Transdermal System 0.2 mg/dayTeva Pharmaceuticals is recalling Clonidine Transdermal System 0.2 mg/day due to the use of an unapproved raw material during manufacturing.
3 products
FDA•MODERATECytal Wound Matrix 2-LayerIntegra LifeSciences is recalling Cytal Wound Matrix 2-Layer 5x5 cm dressings due to out-of-specification endotoxin results.
5 products- Device RecallFDA•MODERATEPhilips AneurysmFlow Software
Philips is recalling AneurysmFlow software due to unreliable MAFA ratio data that may lead to incorrect clinical treatment decisions.
- Device RecallFDA•MODERATELeksell Vantage Arc System
Elekta is recalling the Leksell Vantage Arc System due to locking mechanisms that may fail to secure, causing coordinate shifts.
FDA•MODERATEMedline Neuro SpongesMedline is recalling various neuro sponges due to higher-than-expected endotoxin levels that may exceed safety specifications.
38 products
FDA•MODERATEDonJoy IceMan Classic3 Cold Therapy UnitDJO is recalling the IceMan Classic3 cold therapy unit due to a broken connector that may interrupt cold therapy.
4 products
FDA•MODERATEDiversatek Healthcare Viper 3-Stage Fixed Wire Balloon DilatorDiversatek Healthcare is recalling Viper 3-Stage Fixed Wire Balloon Dilators due to incorrect inflation tag labeling.
4 products
FDA•MODERATEBromfenac Ophthalmic Solution 0.07%Alembic Pharmaceuticals is recalling Bromfenac Ophthalmic Solution 0.07% (NDC 62332-583-03) due to failed impurities and degradation specifications.
FDA•MODERATEDimension Creatinine Flex Reagent CartridgeSiemens is recalling Dimension Creatinine Flex reagent cartridges (lots GA6307, BA7005) due to potential imprecision in patient creatinine results.
FDA•MODERATEOctreotide Acetate for Injectable SuspensionTeva is recalling Octreotide Acetate for Injectable Suspension due to a lack of assurance of sterility.
6 products
FDA•MODERATECurosurf (poractant alfa) 240 mg Intratracheal SuspensionChiesi USA is recalling Curosurf 240 mg intratracheal suspension vials (NDC 10122-510-03) due to lack of sterility assurance.
FDA•MODERATEXanax XR Alprazolam 3 mg TabletsViatris is recalling Xanax XR 3 mg tablets (NDC 58151-506-91) due to failed dissolution specifications.
FDA•MODERATEStraumann Custom Abutment TiStraumann is recalling custom abutments manufactured with incorrect raw materials due to a production mix-up.
2 products
FDA•MODERATEAlbuterol Sulfate Inhalation Solution 0.5%Nephron SC recalling Albuterol Sulfate Inhalation Solution (NDC 69374-330-05) due to illegible labeling.
FDA•MODERATELucerne 2% Cottage CheeseAlbertsons is recalling Lucerne 2% Cottage Cheese due to potential contamination with metal spring fragments.
FDA•MODERATEMeclizine Hydrochloride Tablets 12.5 mgAmerican Health Packaging is recalling Meclizine Hydrochloride 12.5 mg tablets (NDC 60687-775-65 and 60687-775-11) due to failed tablet specifications.
FDA•MODERATECinacalcet Hydrochloride TabletsCipla is recalling Cinacalcet Hydrochloride Tablets due to the presence of N-Nitroso Cinacalcet above acceptable limits.
3 products
FDA•MODERATEMedline CENTURION Circumcision KitMedline is recalling CENTURION Circumcision Kit (CIT7050F) due to one lot distributed without sterilization.
FDA•MODERATEAccess Total T4 CalibratorBeckman Coulter is recalling Access Total T4 Calibrator (Catalog No. 33805) due to negative bias causing falsely low results on DxI 600/800 instruments.
FDA•MODERATEFlamingo Funnel SmallSurgiSmoke Solutions is recalling the Flamingo Funnel Small due to a manufacturing nonconformance involving incompatible sterilization drapes.
3 products
FDA•MODERATEMedline Universal Central/Art Line Insertion KitMedline is recalling convenience kits containing non-sterile alcohol prep pads due to potential bacterial contamination.
10 products
FDA•MODERATELanreotide Injection 120 mg/0.5 mLCipla is recalling Lanreotide Injection 120 mg/0.5 mL due to a lack of assurance of sterility.
2 products
FDA•MODERATENoromycin 300 LA Oxytetracycline InjectionMWI Animal Health is recalling Noromycin 300 LA oxytetracycline injection (NADA# 141-143) due to lack of assurance of sterility.
FDA•MODERATEMagellan Diagnostics LeadCare II Blood Lead Test KitsMagellan Diagnostics is recalling LeadCare II blood lead test kits due to the risk of false positive results.
4 products
FDA•MODERATEBuprenorphine Hydrochloride Injection 0.3mg/mLEndo USA recalls Buprenorphine Hydrochloride Injection 0.3mg/mL vials (NDC 42023-179-05) due to particulate matter contamination.
FDA•MODERATETreasured Harvest Chilli Spanish PeanutsTreasured Harvest Chilli Spanish Peanuts are recalled due to potential glass contamination in the product.
2 products
FDA•MODERATEFavorina Chocolate Ladybugs German-Style NougatLidl is recalling Favorina Chocolate Ladybugs (3.52 oz) due to undeclared tree nut allergen on label.
FDA•MODERATEB.R.A.H.M.S PlGF Plus KRYPTOR In Vitro Diagnostic TestB.R.A.H.M.S PlGF Plus KRYPTOR (Catalog 859075N) recalled for out-of-range quality control values that may cause falsely elevated preeclampsia risk results.
FDA•MODERATEStryker Sustainability Solution Tourniquet CuffsStryker is recalling tourniquet cuffs that may fail to maintain pressure due to a potential detachment at the welding connection.
FDA•MODERATEARTIS Pheno VE30A and VE40A Imaging SystemSiemens is recalling ARTIS Pheno VE30A and VE40A imaging systems (Model 10849000) due to unregulated dose causing unintentional low-dose radiation exposure.
FDA•MODERATEMesh Style Tip ProtectorsHealthmark Industries is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) due to a lack of FDA clearance.
FDA•MODERATELinkBio CORE WorkstationLinkBio CORE Workstation (87-9136) may display incorrect Planning Date on Start Case menu.
FDA•MODERATEiLet Bionic PancreasBeta Bionics is recalling iLet Bionic Pancreas (software 1.4.2–1.4.3) for Dexcom G7 compatibility issues that may disable glucose correction dosing.
FDA•MODERATETETAS Mireya Cherry Milkshake PopsicleASUKAR FOODS CORP is recalling TETAS Mireya Cherry Milkshake popsicles (UPC 83822654822) due to undeclared soy lecithin.
FDA•MODERATE0.9% Sodium Chloride Injection, USPFresenius Kabi is recalling 0.9% Sodium Chloride Injection, USP, 250 mL bags due to a lack of assurance of sterility.
14 products
FDA•MODERATEB Braun IV Administration SetsWindstone Medical Packaging is recalling Pre Op Kits containing B Braun IV administration sets due to potential medication backflow risks.
3 products
FDA•MODERATEMedtronic Sphere-9 Cardiac Ablation CatheterMedtronic Sphere-9 Catheter (Model AFR-00001) may cause ventricular fibrillation in patients with Biotronik ICDs or CRT-Ds during radiofrequency ablation therapy.
FDA•MODERATEArrow Echogenic Introducer NeedleArrow is recalling the Echogenic Introducer Needle due to a manufacturing error with the device's liquid adhesive.
13 products
FDA•MODERATEHorizon Organic Chocolate Lowfat MilkHorizon Organic is recalling chocolate lowfat milk in 8-oz cartons due to compromised package integrity.