FDA•MODERATE
Pantoprazole Sodium Delayed-Release Tablets 40 mg
Camber Pharmaceuticals is recalling Pantoprazole Sodium 40 mg tablets (NDC 31722-713-10) due to discoloration.
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FDA•MODERATEMedline Namic GuidewiresMedline recalls Namic syringes, guidewires, and tubing due to rescinded 510(k) clearances.
28 products
FDA•MODERATEMedline Convenience Kits with 10mL Polycarbonate SyringesMedline is recalling convenience kits containing select 10mL polycarbonate syringes due to potential cracking or breakage of the syringe barrel and/or plunger, which could result in loss of sterility and potential patient infection.
21 products
FDA•MODERATELeadCare II Blood Lead Test KitsMagellan recalls LeadCare II blood lead test kits over false elevated results from certain micro-collection devices.
4 products
FDA•MODERATECUSA Clarity C7000 ConsoleIntegra LifeSciences is recalling CUSA Clarity C7000 Console (Software 2.1.1.909) due to unresponsive touch screen.
FDA•MODERATESoft-Vu Angiographic CatheterAngiodynamics recalls Soft-Vu Angiographic Catheters due to guidewire passage defect.
20 products
FDA•CRITICALMedline Namic Angiographic Control SyringesWindstone recalls kits with Medline Namic RA Syringes over risk of adapter unwinding, which may cause disconnection and serious injury.
FDA•MODERATEDesmopressin Nasal Spray, USP 10 mcg/0.1 mLApotex is recalling Desmopressin Nasal Spray (NDC 60505-0815-0) due to defective bottle caps with missing or dislodged liners.
3 products
FDA•MODERATEMedline CENTURION Circumcision KitMedline is recalling CENTURION Circumcision Kit (CIT7050F) due to one lot distributed without sterilization.
FDA•MODERATEPhilips Spectral CT on RailsPhilips Spectral CT on Rails (Model 728334) requires a software update to address gantry positioning, message display, and menu option issues.
FDA•MODERATEEpinephrine Injection USP 1 mg/10mLInternational Medication Systems is recalling Epinephrine Injection 1 mg/10mL (NDC 76329-3318-1) due to lack of sterility assurance.
FDA•MODERATECytal Wound Matrix 2-Layer 5x5 cmCytal Wound Matrix 2-Layer 5x5 cm recalled over out-of-specification endotoxin results.
5 products
FDA•MODERATEReact Health PHOENIX 5L Oxygen ConcentratorReact Health PHOENIX 5L Oxygen Concentrator recalled due to devices not meeting quality specifications.
FDA•CRITICALB. Braun STREAMLINE Bloodline SetB. Braun recalls STREAMLINE bloodline sets for Dialog DR over arterial line air bubble risk.
6 products
FDA•MODERATEElegance Anterior Cervical PlatesClariance-SAS is recalling Elegance Anterior Cervical Plates due to the presence of burrs on the finished product.
2 products
FDA•MODERATERiverence Smoked Trout DipRiverence is recalling Smoked Trout Dip due to an undeclared milk allergen.
FDA•MODERATEHuons: Multiple Rx Only InjectionsHuons recalls injectable lidocaine, bupivacaine, and saline due to sterility concerns.
9 products
FDA•LOWIsland Kinetics: multiple gelsIsland Kinetics recalls hydrocortisone 1% gels (Remedy Gel, Skin Rehab, Essential Calming) due to subpotency.
3 products
FDA•MODERATEAlbuterol Sulfate Inhalation Solution 0.5%Nephron SC recalling Albuterol Sulfate Inhalation Solution (NDC 69374-330-05) due to illegible labeling.
FDA•MODERATEFluocinonide 0.05% Cream 15gTaro recalls Fluocinonide 0.05% Cream 15g tubes due to out-of-spec viscosity.
3 products
FDA•MODERATEInstinct Plus Endoscopic Clipping DeviceWilson-Cook Medical is recalling the Instinct Plus Endoscopic Clipping Device due to a potential for the device to malfunction.
FDA•MODERATEHydroPeptide Clear Alliance SerumHydroPeptide Clear Alliance Serum recalled due to benzene contamination.
4 products
FDA•MODERATECinacalcet Hydrochloride Tablets 30 mgCipla recalls Cinacalcet HCl 30 mg tablets over N-Nitroso impurity above acceptable limit.
3 products
FDA•MODERATEExchange Select Honey Lemon Cough DropsExchange Select Honey Lemon Cough Drops recalled over quality concerns from FDA inspection.
15 products
FDA•MODERATERemel Yeastone BrothRemel is recalling Yeastone Broth due to the potential for incorrect antimicrobial susceptibility testing results.
FDA•MODERATELinkBio CORE WorkstationLinkBio CORE Workstation (87-9136) may display incorrect Planning Date on Start Case menu.
- Device RecallFDA•MODERATEPhilips AneurysmFlow Software
Philips is recalling AneurysmFlow software because the MAFA ratio provides unreliable prognostic data for aneurysm treatment decisions.
FDA•MODERATEArjo Tenor Mobile Patient LiftArjo Tenor patient lifts (Models KHA1000 US, KHA1010 US) recalled for actuator failure risk causing sudden arm drop.
FDA•MODERATELanreotide Injection 120 mg/0.5 mLCipla recalls Lanreotide Injection 120 mg/0.5 mL over sterility assurance concerns.
2 products
FDA•MODERATEOmnipaque (iohexol) Injection 350 mg/mLGE Healthcare recalls Omnipaque (iohexol) Injection 350 mg/mL due to particulate matter.
2 products
FDA•CRITICALBlaine Labs: multiple drugsBlaine Labs recalls multiple topical antiseptic/antifungal gels and creams due to Lysinibacillus fusiformis contamination.
9 products
FDA•LOWPocas International: 4 Popping Boba RTD TeasPocas recalls Popping Boba RTD teas over packaging integrity issue.
4 products
FDA•MODERATEImu-Tek Animal Health: 2 productsImu-Tek recalls Colostrum-5 capsules and powder due to under-processing.
2 products
FDA•MODERATEDivided Sunset Multi Collagen PeptidesDivided Sunset Multi Collagen Peptides are recalled for failing to declare egg and fish allergens on the product label.
FDA•MODERATEXanax XR Alprazolam 3 mg TabletsViatris is recalling Xanax XR 3 mg tablets (NDC 58151-506-91) due to failed dissolution specifications.
FDA•MODERATEB.R.A.H.M.S PlGF Plus KRYPTORBrahms recalls PlGF Plus KRYPTOR test (REF 859075N) due to QC underestimation risk causing false preeclampsia risk classification.
FDA•MODERATEVancomycin HCl 1.5g in 250mL Sodium Chloride InjectionFagron recalls Vancomycin HCl 1.5g/250mL injection due to sterility concern.
5 products
FDA•MODERATEGeri-Care Artificial Tears Lubricant Eye DropsGeri-Care Artificial Tears Lubricant Eye Drops (0.5 oz, NDC 68788-7266-0) recalled due to lack of sterility assurance.
FDA•CRITICALMedline Convenience Kits with Namic RA SyringesMedline recalls convenience kits with Namic RA syringes over risk of loose connection or disconnection during use.
25 products
FDA•MODERATEARTIS pheno and ARTIS Icono Biplane X-ray SystemSiemens is recalling ARTIS pheno and ARTIS Icono X-ray systems (Models 10849000, 11327600, 11328100, 11327700) due to erroneous dose display during patient exams.
FDA•MODERATESpacelabs Multi-parameter Command Module Model 91496Spacelabs is recalling Model 91496 Multi-parameter Command Module due to circuit board issue causing inaccurate cardiac output readings.
FDA•MODERATESee Luer Cap Set MPC-130Molded Products is recalling See Luer Cap Set MPC-130 due to threaded sleeve detachment risk.
FDA•MODERATEFresenius Kabi: Multiple Sale NDC Number InjectionsFresenius Kabi recalls 14 lots of Sodium Chloride and Dextrose Injections due to sterility concerns.
14 products
FDA•MODERATETornier HRS Max Tuberosity Body and Trial PartsTornier is recalling shoulder system components incorrectly labeled as HRS Max parts, as they are incompatible with the HRS Max system.
FDA•MODERATEMedline Anterior Hip Pack Biopsy ValveMedline is recalling Anterior Hip Packs containing Olympus biopsy valves over risk of rubber fragment detachment.
8 products
FDA•MODERATESIGNA Premier MR Scanner Magnet FittingsGE Healthcare is recalling SIGNA Premier MR scanners due to ferrous magnet fittings that could cause personnel injury during service.
FDA•MODERATEMedtronic MiniMed Insulin PumpsMedtronic MiniMed recalls all Paradigm, 600, and BLE 700 series insulin pumps over insulin delivery errors that can cause severe hypoglycemia or ketoacidosis.
14 products
FDA•MODERATEBurlington Medical Wrap ApronsBurlington Medical wrap aprons may lose shielding effectiveness over time.
13 products
FDA•MODERATEOXOID Microbact 12L Listeria Identification KitOxoid is recalling Microbact 12L Listeria Kit (MB1128A, Lot 4494873) due to risk of incorrect organism identification from ambiguous color reactions.
- Device RecallFDA•CRITICALPhilips Respironics Trilogy Evo O2 Ventilator
Philips Respironics recalls Trilogy Evo O2 ventilators (SW 1.05.15.00) over delayed obstruction alarm.
4 products