Device Recall
FDA•MODERATE
HealthCast Vital Sync Remote Patient Monitoring System
HealthCast is recalling Vital Sync software due to a failure to transmit or receive critical patient bedside monitor alarms.
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FDA•MODERATEEndoVive Safety PEG KitBoston Scientific is recalling EndoVive Safety PEG Kits due to compromised seals on the included antiseptic swabsticks.
FDA•MODERATELowes Foods Sour Cream and Onion Potato ChipsUncle Ray's recalls Lowes Foods sour cream & onion chips (8 oz) over inaccurate nutrition and undeclared MSG.
FDA•MODERATEEndo-Model Replacement PlateauEndo-Model Replacement Plateau is recalled due to a risk of bushing detachment from the screw shaft caused by longitudinal fractures.
13 products
FDA•MODERATEGEM Premier 5000 PAKInstrumentation Laboratory is recalling GEM Premier 5000 PAK cartridges due to errors that may cause ejection and delay patient results.
20 products
FDA•MODERATEPhysio-Control Infant/Child Defibrillator ElectrodesPhysio-Control is recalling infant/child defibrillator electrodes due to a risk of delamination that could impact therapy delivery.
2 products
FDA•MODERATEAPTUS 2.5 TriLock ScrewsMedartis is recalling APTUS 2.5 TriLock Screws (model A-5750.16/1) due to a mix-up with 2.8mm screws.
2 products
FDA•MODERATEVegetarian Chicken Flavor RamenPalmetto Gourmet Foods is recalling Vegetarian Chicken Flavor Ramen 3oz packages due to undeclared Yellow #5.
2 products
FDA•MODERATEEquinoxe Core Instrument KitExactech recalls Equinoxe Core Instrument Kit and Ergo Impactor Handle over missing cross-pin risk.
2 products
FDA•LOWC2O Coconut Water with Pulp 17.5 ozC2O Coconut Water with Pulp 17.5 oz recalled over incorrect outer box labeling omitting added sugar.
FDA•MODERATERaz Mobile Shower Commode ChairsRaz Design is recalling various mobile shower commode chairs due to a seat bracket issue that may pose a fall risk to users.
2 products
FDA•MODERATEMedline Unna-Z Stretch Zinc Paste BandageMedline is recalling Unna-Z Stretch Zinc Paste Bandages due to an incomplete ingredient list on the label.
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•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•MODERATEHTO Nevada: Multiple Dermal Source ProductsKirkman recalls Vasocaine Spray and Zone 1/2 Lidocaine Creams over unsupported expiry dates.
3 products
FDA•MODERATEOlympus ShockPulse-SE Lithotripsy System GeneratorOlympus is recalling the ShockPulse-SE Lithotripsy System generator due to a wiring issue that may cause treatment delays.
2 products
FDA•Miss Vickie's Spicy Dill Pickle Potato ChipsFrito-Lay recalls Miss Vickie's Spicy Dill Pickle chips (8 oz.) over undeclared milk allergen.
FDA•MODERATEVergani Pandoro Classico Gluten FreeVergani Pandoro Classico Gluten Free recalled due to possible Teflon fragments.
FDA•MODERATEMedline Nail KitMedline is recalling the Nail Kit (model DYKM1528) because the included sterile saline wound wash may not meet sterility requirements.
5 products
FDA•MODERATEBader Enterprises: 2 Clear Flexible Plastic PackagingsBader Enterprises recalls Premium Food Jordan Almonds and Bubble Gum for undeclared wheat and FD&C Blue 1 & 2 Lake.
2 products
FDA•LOWCipla: Multiple Packaged In Cartons CapsulesCipla recalls Nilotinib 150 mg and 200 mg capsules over failed specification tests.
2 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•MODERATEOlympus Single Use Biopsy ValveOlympus is recalling the MAJ-210 single use biopsy valve due to the potential for rubber fragments to detach during use.
2 products- Device RecallFDA•MODERATEDatascope CS300 IABP
Datascope is updating the Instructions for Use for the CS300 IABP (software version C.01) to correct battery runtime and cycle specifications.
2 products 
FDA•MODERATESTA Liatest Free Protein S KitDiagnostica Stago is recalling the STA Liatest Free Protein S kit due to potential underestimation of protein S levels in normal plasma.
FDA•MODERATEACME UNITED: multiple drugsAcme United is recalling 22 varieties of BZK Antiseptic Towelettes due to manufacturing process deviations.
22 products
FDA•MODERATESemaglutide Bulk APIHarbin Jixianglong recalls semaglutide bulk API over CGMP validation failures.
2 products- Device RecallFDA•MODERATEB. Braun 21G Winged Infusion Set
B. Braun recalls 21G winged infusion sets due to risk of dull or broken needle tip.
3 products 
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•MODERATEAesculap Minop TrocarAesculap is recalling the Minop Trocar 150mm because the shaft may be too long.
FDA•MODERATEAtellica CH Urine Albumin TestSiemens is recalling Atellica CH Urine Albumin tests (Material 11537225) due to falsely depressed results in high-concentration samples.
FDA•MODERATESavannah Bee Honey BBQ Sauce MustardSavannah Bee Honey BBQ Sauce "Mustard" bottles may contain "Sweet" sauce with undeclared wheat and soy.
FDA•Rhino Choco VIP 10X ChocolateRhino Choco VIP 10X Chocolate recalled for undeclared Tadalafil; return for refund.
FDA•MODERATETeva Pharmaceuticals: multiple tabletsTeva recalls Metoprolol Succinate ER tablets (25-200 mg) over failed dissolution specs.
4 products
FDA•CRITICALImpella RP Flex with SmartAssistAbiomed recalls Impella RP Flex with SmartAssist due to sensor drift risk.
3 products
FDA•MODERATECobas Pro Integrated Solutions Analytical UnitsRoche is recalling Cobas Pro analytical units due to a software defect that can cause the system to report erroneous, repeated test results.
2 products
FDA•MODERATEGE Healthcare Centricity Universal ViewerGE Healthcare is recalling Centricity Universal Viewer software due to a risk of patient information and image mismatch.
FDA•CRITICALFish Ball: 3 Pieces Per PiecesKOI fish balls are being recalled because they contain undeclared wheat and sesame, which are allergens and pose a risk to people with wheat or sesame allergies.
3 products
FDA•MODERATEValley Springs Artesian Gold: 4 Bottled By Valley SpringsValley Springs recalls bottled water products due to insanitary bottling conditions.
4 products
FDA•MODERATEOctopus Nuvo Tissue StabilizerMedtronic is recalling Octopus Nuvo Tissue Stabilizer (TSMICS1) due to incorrect tubing assembly that may affect surgical tissue stabilization.
FDA•MODERATECampy CVA MediumRemel is recalling Campy CVA Medium (R01272) due to low recovery of Campylobacter Jejuni on identified lots.
FDA•MODERATEAgiliti Adapt PumpAgiliti is recalling the Adapt Pump (model 61600200) for a software failure that prevents the Microclimate Management function from restarting.
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•CRITICALThe Tuna Salad product: 2 productsReser's recalls Molly Kitchen's Tuna Salad mislabeled as Chicken Salad; undeclared fish allergen.
2 products
FDA•MODERATETiki Bar Dark Chocolatey Peanut Butter & PretzelTiki Bar Dark Chocolatey Peanut Butter & Pretzel is recalled for an undeclared peanut allergen.
FDA•MODERATEWoodland Gourmet Arrowroot FlourWoodland Foods is recalling 55 lb. bags of Arrowroot Flour due to the potential presence of foreign material.
FDA•Boner Bears Chocolate SyrupLockout Supplements recalls Boner Bears Chocolate Syrup due to undeclared sildenafil, which may dangerously lower blood pressure.
FDA•MODERATESAPUTO CHEESE: 5 productsSaputo recalls Clover Sonoma and Great Value cottage cheese and sour cream over potential under-pasteurization.
5 products
FDA•CRITICALAll Natural Chicken Chips for DogsElite Treats is recalling All Natural Chicken Chips for Dogs due to potential Salmonella contamination.
FDA•CRITICALIQF BlueberriesOregon Potato Company is recalling IQF blueberries in 30 lbs. cases and 1400 lbs. totes due to potential Listeria monocytogenes contamination.