FDA•MODERATE
Aptima HPV Assay
Hologic is recalling the Aptima HPV assay (catalog 303585) due to the potential for invalid or false negative results.
Filters
Category
Agency
Severity
All Recalls
Back to home ←
FDA•MODERATECub Pediatric Crib Model FL19HStryker is recalling Cub Pediatric Crib Model FL19H over missing access door warning labels.
FDA•MODERATEWelch Allyn Spot Vision Screener VS100Welch Allyn is recalling the Spot Vision Screener VS100 due to a screen flickering issue that may pose a seizure risk.
FDA•MODERATESterile Radiology Procedure Kits Model DYNDH1491BMedline is recalling Sterile Radiology Procedure Kits Model DYNDH1491B due to potential sterile pouch packaging breach.
FDA•MODERATEWawa Reduced Fat Milk 2% 16 ozWawa is recalling 16 oz pints of Reduced Fat Milk 2% due to potential plastic contamination.
4 products
FDA•MODERATEMidodrine Hydrochloride Tablets, USP 5 mgMajor Pharmaceuticals is recalling Midodrine Hydrochloride Tablets 5 mg (NDC 0904-6818-06) due to inadequately sealed blister packaging.
FDA•MODERATESee Luer Cap Set MPC-130Molded Products is recalling See Luer Cap Set MPC-130 due to threaded sleeve detachment risk.
FDA•MODERATEMedline Airway Exam Kit Biopsy ValveMedline is recalling Airway Exam Kits containing Olympus biopsy valves due to a risk of rubber fragment detachment during use.
8 products
FDA•MODERATEConvatec EsteemBody Drainable PouchConvaTec is recalling the EsteemBody Drainable Pouch due to a manufacturing issue that may cause the pouch to leak.
3 products
FDA•MODERATEKLG Kesar MukhwasGanesha Enterprises is recalling KLG Kesar Mukhwas (200 gm) for undeclared food colorings and unapproved dye.
FDA•MODERATESemaglutide Compounding APIHarbin Jixianglong Biotech is recalling Semaglutide API due to failures in process and bacterial endotoxin method validation.
2 products
FDA•MODERATEAmantadine HCl Capsules 100 mgAvKARE is recalling Amantadine HCl Capsules 100 mg (NDC 50268-069-15) nationwide due to failed dissolution specifications.
FDA•MODERATEMedtronic MiniMed Infusion PumpsMedtronic is recalling various MiniMed infusion pumps due to potential insulin over- or under-delivery risks.
14 products
FDA•MODERATEMedline ENFit G-Tube Connector KitsMedline is recalling G-Tube care and discharge kits due to connector defects that may cause leakage and fluid loss.
2 products
FDA•MODERATEPurina Nature's Match Sow & Pig Complete FeedPurina is recalling 50 lb bags of Nature's Match Sow & Pig Complete Feed (UPC 804273051451) due to elevated Deoxynivalenol levels.
FDA•LOWEptifibatide Injection 75 mg/100 mLSlate Run Pharmaceuticals recalls Eptifibatide Injection 75 mg/100 mL vials (NDC 70436-027-80, 70436-163-80) due to incorrect dosing-route labeling.
FDA•MODERATEOlympus Endoscope Suction ValvesOlympus is recalling MAJ-1443 and MAJ-1444 endoscope suction valves due to compatibility issues with specific automated reprocessors.
4 products
FDA•MODERATEXZL Jelly SnacksXZL Jelly Snacks are recalled due to undeclared FD&C Yellow #5, Yellow #6, and Red #40 food dyes.
FDA•MODERATEBurlington Medical Wrap ApronsBurlington Medical is recalling Wrap Aprons due to potential attenuation degradation that may reduce their protective lifespan.
13 products
FDA•MODERATEEmbrace Shoulder Instrument Drill TowerWaldemar Link is recalling the Embrace Shoulder Instrument Drill Tower (645-081/62) due to incorrect article numbers in the surgical manual.
2 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•MODERATEWellsley Farms Farm-Raised Atlantic SalmonWellsley Farms Farm-Raised Atlantic Salmon (32 oz) recalled for Listeria monocytogenes contamination.
FDA•MODERATEVergani 1944 Milano Pandoro Classico Gluten FreeItalianway Import is recalling Vergani 1944 Milano Pandoro Classico Gluten Free due to potential Teflon fragment contamination.
FDA•MODERATEAdbry (tralokinumab-ldrm) Injection 300 mg/2mLLEO Pharma is recalling Adbry injection autoinjectors (NDC 50222-350-91, 50222-350-02) due to wool fiber contamination affecting sterility.
FDA•MODERATEOrtho Dev. Trimax Lantern Knee Drill PlateOrtho Dev. Trimax Drill Plates for the Lantern Knee System are recalled due to a manufacturing error causing excessive bone cut depth.
2 products
FDA•MODERATEArtegraft Vascular GraftLeMaitre Vascular is recalling the Artegraft Vascular Graft due to a labeling mix-up on the outer packaging.
FDA•MODERATEPuracol and Puracol Plus Collagen Wound DressingsMedline is recalling Puracol collagen wound dressings due to elevated endotoxin levels that may cause severe inflammatory responses.
FDA•MODERATEEndoVive Safety PEG KitBoston Scientific is recalling EndoVive Safety PEG Kits due to potentially compromised sterile packaging on the included ChloraPrep swabsticks.
FDA•MODERATEFrozen Cooked Medium ShrimpH & N Group is recalling 1 lb bags of frozen cooked medium shrimp due to potential Cesium-137 contamination.
FDA•MODERATEHortex Spring Vegetable MixHortex Spring vegetable mix is being recalled due to potential glass contamination.
FDA•MODERATECetrorelix Acetate for Injection Kit 0.25 mgMeitheal Pharmaceuticals recalls Cetrorelix Acetate injection kits (NDC 71288-558-90) due to missing or duplicated needles.
FDA•MODERATERefleXion X1 Radiotherapy System Model RXM1000RefleXion X1 Radiotherapy System Model RXM1000 recalled for software defect causing incorrect radiation dose delivery.
FDA•MODERATEID NOW Influenza A & B 2 Test KitAbbott is recalling ID NOW Influenza A & B 2 test kits due to a higher-than-expected rate of invalid test results.
FDA•MODERATEsmart & simple Turmeric PelletsSmartPak Equine is recalling smart & simple Turmeric Pellets due to elevated aflatoxin levels.
FDA•MODERATEValley Springs 100% Natural Bottled WaterValley Springs is recalling 100% Natural Bottled Water in 1 Gal jugs due to insanitary bottling conditions.
4 products
FDA•MODERATEArtelon FlexBand Dynamic MatrixInternational Life Sciences is recalling the Artelon FlexBand Dynamic Matrix due to failure to meet bacterial endotoxin testing requirements.
3 products
FDA•MODERATEBD Kiestra ReadABD Kiestra ReadA modules may experience connectivity issues after a reboot, potentially delaying plate retrieval.
- Device RecallFDA•LOWDatascope Cardiosave Battery Charging Station
Datascope is recalling the Cardiosave Battery Charging Station due to a design defect in the left bay that prevents proper battery charging.
FDA•MODERATEHitachi Proton Beam Therapy SystemHitachi is recalling the Proton Beam Therapy System (PROBEAT-FR) due to a software anomaly that may cause patient positioning discrepancies.
2 products
FDA•MODERATETippy Toes Apple Pear Banana Baby FoodTippy Toes Apple Pear Banana baby food is being recalled due to potential patulin contamination.
FDA•MODERATEThiamine HCl InjectionFagron Sterile Services is recalling Thiamine HCl 500 mg injection due to a lack of assurance of sterility.
5 products
FDA•MODERATECampy CVA MediumRemel is recalling Campy CVA Medium (R01272) due to low recovery of Campylobacter Jejuni on identified lots.
FDA•MODERATESTA Liatest D-Di KitDiagnostica Stago is recalling the STA Liatest D-Di kit due to a positive bias in D-Dimer measurements that may cause inaccurate results.
2 products
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•MODERATESTA Liatest Free Protein SDiagnostica Stago is recalling STA Liatest Free Protein S kits due to the risk of inaccurate test results for normal patient plasma levels.
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.