Device Recall
FDA•MODERATE
Datascope CS300 IABP
Datascope is updating the Instructions for Use for the CS300 IABP (software version C.01) to correct battery runtime and cycle specifications.
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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.
FSIS•MODERATEPunahele Jerky Beef CrispsPunahele Jerky beef crisps recalled for undeclared soy allergen; best by 2/17/2027 or prior.
4 products
FDA•MODERATESavannah Bee Honey BBQ Sauce MustardSavannah Bee Honey BBQ Sauce "Mustard" bottles may contain "Sweet" sauce with undeclared wheat and soy.
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•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.
FDA•LOWLubna Quality Products Mung BeansLubna Quality Products is recalling 4 lb mung bean packages due to unapproved pesticide (Thiamethoxam) contamination.
FDA•MODERATEMedline Apheresis and Dialysis KitsMedline is recalling kits containing Tego Connectors due to potential silicone seal defects that may cause fluid leakage or therapy delays.
6 products
FDA•MODERATEEncore Medical Knee and Shoulder ImplantsEncore Medical is recalling EMPOWR 3D Knee and RSP Humeral Socket implants due to incorrect labeling.
3 products
FDA•MODERATEPIE PAK Trolley SystemEdermy is recalling PIE PAK trolley systems (models P2HC-A, P2HC-S, P2HC) due to a lack of required 510(k) clearance.
2 products
FSIS•CRITICALSiluriformes Fish ProductsSobico USA LLC is recalling approximately 36-pound cases of frozen, raw intact Siluriformes fish, including whole gutted fish and steaks, because the products were imported from Vietnam without the benefit of reinspection.
2 products
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•MODERATEAmantadine HCl Capsules 100 mgAvKARE is recalling Amantadine HCl Capsules 100 mg (NDC 50268-069-15) nationwide due to failed dissolution specifications.
FDA•MODERATEAdbry (tralokinumab-ldrm) InjectionLEO Pharma is recalling Adbry (tralokinumab-ldrm) injection due to a lack of sterility assurance following the discovery of wool fiber.
FSIS•CRITICALBremer Italian Style MeatballsRosina recalls frozen Bremer Italian Style Meatballs over possible metal contamination.
FDA•CRITICALMade Fresh Salads: 14 Brand TubsMade Fresh Salads recalls 14 varieties of 5 lb whipped cream cheese over possible Listeria contamination.
14 products
FDA•MODERATEGerber Arrowroot BiscuitsGerber Arrowroot Biscuits (5.5 oz, UPC 015000005962) recalled for potential paper/plastic contamination in arrowroot flour.
FDA•MODERATEHitachi Proton Beam Therapy SystemHitachi recalls Proton Beam Therapy System over patient positioning software anomaly.
2 products- Food RecallFDA•MODERATEKeto-C Antiseptic Wipes
Stratford Care USA is recalling Keto-C Antiseptic Wipes (50ct) due to misbranding; product contains non-medicated otic flush instead of labeled antiseptic.
36 products 
FDA•MODERATESpicy Breakfast Burrito 10 ozMG Foods recalls Spicy Breakfast Burrito 10 oz over possible plastic fragments.
FDA•MODERATETKS Co-pack Manufacturing: 2 productsAonic recalls His & Hers supplement shots over possible E. coli and coliform contamination.
2 products
FDA•MODERATEFrozen Cooked Medium ShrimpH & N Group is recalling 1 lb bags of frozen cooked medium shrimp due to potential Cesium-137 contamination.
FDA•MODERATEMcCain Foods: 2 productsMcCain Foods recalls Ore-Ida Tater Tots and Sonic Tots over possible small hard plastic fragments.
2 products
FDA•MODERATERed Button Movie House PopcornRed Button Movie House Popcorn is being recalled due to the potential presence of foreign material.
FDA•LOWSodexo Stars Saccharin PacketsDomino Foods recalls Sodexo Stars Saccharin Packets due to undeclared aspartame.
FDA•CRITICALKirkland Signature Mini BeignetsKirkland Signature Mini Beignets are recalled due to undeclared hazelnut, which poses a risk to consumers with allergies.
FDA•CRITICALUdenyca Pegfilgrastim-cbqv InjectionAccord BioPharma is recalling Udenyca injection due to improper storage temperature conditions.
FDA•MODERATEOxycodone Hydrochloride 5 mg TabletsAmerican Health Packaging is recalling Oxycodone 5 mg tablets due to defective blister card seals that may cause tablets to fall out.
FDA•MODERATECetrorelix Acetate Injection KitMeitheal Pharmaceuticals is recalling Cetrorelix Acetate injection kits due to missing or duplicated needles in the delivery system.
FDA•CRITICALOlympus High Flow Insufflation UnitOlympus is recalling the UHI-3 High Flow Insufflation Unit due to a software issue that may cause dangerous overpressure events.
3 products