Device Recall
FDA•CRITICAL
Philips Respironics Trilogy Evo O2 Ventilator
Philips Respironics recalls Trilogy Evo O2 ventilators (SW 1.05.15.00) over delayed obstruction alarm.
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FDA•MODERATECardinal Health Monoject Tuberculin Syringe 1 mLCardinal Health is recalling Monoject Tuberculin Syringes (Catalog 1180100777) that contain U-100 insulin syringes instead, risking dosing errors.
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•CRITICALCentrosFLO Hemodialysis CathetersMerit Medical recalls CentrosFLO Hemodialysis Catheters over sheath introducer defect that may cause hemorrhage and other serious complications.
5 products
FDA•MODERATEPrazosin Hydrochloride Capsules 1mgAppco Pharma recalls Prazosin HCl 1mg capsules over nitrosamine impurity (NNP) above acceptable limits.
3 products
FDA•MODERATEK.C. Pharmaceuticals: Multiple Eye DropsK.C. Pharmaceuticals recalls multiple brands of sterile eye drops over sterility concerns.
15 products
FDA•MODERATEJFE FRANCHISING: 7 productsJFE recalls Dumpling Party Trays and Loaded Dumpling Vegetable products over possible glass contamination.
7 products
FDA•MODERATETramadol Hydrochloride Tablets 50 mgAmneal is recalling 500-count bottles of Tramadol Hydrochloride 50 mg tablets due to an impurity found during stability testing.
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•MODERATESynthes VOLT Locking Screw TapSynthes recalls VOLT Locking and Cortical Screw Taps due to incorrect thread from a lot swap.
2 products
FDA•MODERATEOlympus SOLTIVE Laser SystemOlympus recalls SOLTIVE laser systems (TFL-SLS, TFL-PLS) due to power supply defect that may cause inoperability and smoke.
2 products
FDA•MODERATEOctreotide Acetate Injectable Suspension 20 mgTeva recalls Octreotide Acetate 20 mg vials over sterility assurance concerns.
6 products
FDA•MODERATEArtoura Breast Tissue ExpandersA recall was issued for Artoura Breast Tissue Expanders due to infusion sets that may contain dull or blunt needle tips.
7 products
FDA•MODERATEPhilips Allura Xper FD10/FD20 Wired Foot SwitchPhilips recalls Allura Xper FD10/FD20 systems over wired foot switch failure causing intermittent X-ray imaging.
22 products
FDA•MODERATEMedline ENFit G-Tube ConnectorMedline recalls ENFit G-tube connectors in care/discharge kits over seal failure and leakage risk.
2 products
FDA•MODERATEEmbrace Drill TowerWaldemar Link recalls Embrace Drill Tower instruments over mixed-up article numbers in the surgical technique overview.
2 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•MODERATERefleXion X1 Radiotherapy System Model RXM1000RefleXion X1 Radiotherapy System Model RXM1000 recalled for software defect causing incorrect radiation dose delivery.
FDA•MODERATESterile Radiology Procedure Kits Model DYNDH1491BMedline is recalling Sterile Radiology Procedure Kits Model DYNDH1491B due to potential sterile pouch packaging breach.
FDA•MODERATEStryker CHROMOPHARE Softlit Ring Surgical LightStryker is recalling the CHROMOPHARE Softlit Ring Surgical Light System due to a potential ceiling cover support failure.
FDA•MODERATEParadise Ultrasound Renal Denervation CatheterReCor Medical is recalling the Paradise Ultrasound Renal Denervation Catheter (Model PRDS-068-02) as these units were intended to be scrapped.
3 products
FDA•MODERATEVue Motion V12 Imaging SystemPhilips Vue Motion V12 (1017979) may display image frames out of sequence during dynamic imaging runs.
FDA•MODERATEPuracol and Puracol Plus Collagen Wound DressingsMedline is recalling Puracol and Puracol Plus wound dressings due to elevated endotoxin levels that may cause severe inflammatory responses.
FDA•MODERATEAtellica CH Enzymatic Hemoglobin A1c AssaySiemens is recalling the Atellica CH A1c_E assay due to a risk of depressed results when used alongside the RCRP assay on the same analyzer.
- Device RecallFDA•CRITICALPhilips Respironics Trilogy Evo Ventilator
Philips Respironics recalls Trilogy Evo ventilators over tidal volume discrepancy with non-pneumatic nebulizers.
4 products 
FDA•MODERATEBD Alaris System with Guardrails Suite MXBD Alaris System labeling lacks required TLS version specification for secure Wi-Fi communication with Point-of-Care Units.
FDA•MODERATEBrimonidine Tartrate/Timolol Maleate Ophthalmic SolutionApotex is recalling Brimonidine Tartrate/Timolol Maleate eye drops (NDC 60505-0589-1) due to lack of sterility assurance.
FDA•MODERATEOlympus PKS Cutting ForcepsOlympus recalls PKS Cutting Forceps over jaw breakage risk from defective welds.
7 products
FDA•MODERATEMICS3 Angled Sagittal Saw AttachmentHowmedica Osteonics is recalling the MICS3 Angled Sagittal Saw Attachment due to a risk of external screws loosening and detaching during use.
FDA•CRITICALMagnesium Sulfate in Water for Injection IV BagsAmneal recalls Magnesium Sulfate IV bags due to product mix-up with Tranexamic Acid.
FDA•MODERATELevothyroxine Sodium Tablets USP 150 mcgMacleods Pharma recalls Levothyroxine Sodium 150 mcg tablets (NDC 33342-401-44) nationwide due to subpotency.
FDA•MODERATELantern Knee System Drill PlateThe Lantern Knee System drill plate is recalled due to a manufacturing error that may cause excessive bone cuts during surgery.
2 products
FDA•MODERATEMiniMed 780G Insulin PumpMedtronic is recalling MiniMed 780G insulin pumps (models MMT-1884, MMT-1886) over software defects that may cause inaccurate insulin delivery.
FDA•MODERATEStraumann Custom Abutment TiStraumann recalls Custom Abutment Ti for Straumann RC due to material mix-up.
2 products
FDA•MODERATETECNIS Eyhance IOL with Simplicity Delivery SystemAMO is recalling TECNIS Eyhance IOLs with Simplicity Delivery System (model DIB00) because the lens may fail to unfold properly.
2 products
FDA•MODERATEBiDop 3 Pocket DopplerKoven Technology is recalling the BiDop 3 Pocket Doppler due to unauthorized fetal indication labeling.
2 products
FDA•MODERATEI.T.S. Headless Compression Screw SystemI.T.S. is recalling Headless Compression Screw System components due to updated MRI safety testing showing higher temperature risks.
24 products
FDA•CRITICALHandy Solutions Neck & Shoulders Heating PadHandy Solutions Neck & Shoulders Heating Pad (Model 25607) may overheat and cause burns if folded or placed under the body.
FDA•MODERATEAjinomoto Foods North America: 11 productsAjinomoto recalls frozen fried rice and gyoza dumplings over possible glass contamination.
11 products
FDA•MODERATEChilli Spanish Peanuts: 2 productsWestern Mixers recalls Chilli Spanish Peanuts (First Street 11 oz, Treasured Harvest 25 lb) due to possible glass contamination.
2 products
FDA•LOWSodium Iodide I-131 Kit Gelatin Capsule PackRadnostix is recalling Sodium Iodide I-131 Kit capsule packs due to failed product specifications.
FDA•CRITICALErbe Flexible CryoprobeErbe USA recalls Flexible Cryoprobes because probes may rupture or burst during use.
4 products
FDA•MODERATEOlympus Endoscope Air/Water and Suction ValvesOlympus recalls endoscope valves MAJ-1444 and MAJ-1443 over reprocessor incompatibility.
4 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•MODERATEDexamethasone Sodium Phosphate Injection, USP 100 mg/10 mLSomerset Therapeutics is recalling Dexamethasone Sodium Phosphate Injection (NDC 70069-025-10/01) due to out-of-specification impurities at expiry.
FDA•LOWDatascope Cardiosave Battery Charging StationDatascope is recalling the Cardiosave battery charging station due to a screw defect in the left bay that prevents proper charging.
FDA•MODERATELeksell Gamma Knife Radiosurgery SystemElekta is recalling Leksell Gamma Knife Perfexion, Icon, and Esprit systems due to potential adapter misalignment during radiation delivery.
FDA•MODERATEArtegraft Vascular GraftLeMaitre Vascular is recalling the Artegraft Vascular Graft due to a labeling mix-up on the outer packaging.
FDA•MODERATEConvatec EsteemBody Drainable PouchConvaTec recalls EsteemBody drainable pouches over possible leakage from a manufacturing issue.
3 products
FDA•MODERATEAptima HPV AssayHologic is recalling the Aptima HPV Assay due to the potential for the test to generate invalid or false negative results.