
FDA•CRITICAL
Impella RP Flex with SmartAssist
Abiomed recalls Impella RP Flex with SmartAssist due to sensor drift risk.
3 products
Abiomed recalls Impella RP Flex with SmartAssist due to sensor drift risk.
3 products
Roche is recalling Cobas Pro analytical units due to a software defect that can cause the system to report erroneous, repeated test results.
2 products
GE Healthcare is recalling Centricity Universal Viewer software due to a risk of patient information and image mismatch.

KOI 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
Valley Springs recalls bottled water products due to insanitary bottling conditions.
4 products
Medtronic is recalling Octopus Nuvo Tissue Stabilizer (TSMICS1) due to incorrect tubing assembly that may affect surgical tissue stabilization.

Remel is recalling Campy CVA Medium (R01272) due to low recovery of Campylobacter Jejuni on identified lots.

Agiliti is recalling the Adapt Pump (model 61600200) for a software failure that prevents the Microclimate Management function from restarting.

Weber is recalling metal wire bristle grill brushes (models 6277, 6278, 6463, 6464, 6493, 6494) due to a serious ingestion hazard.

Pure Solutions recalling 1 fl oz sleep formula bottles due to undeclared milk allergen from bovine colostrum.

Reser's recalls Molly Kitchen's Tuna Salad mislabeled as Chicken Salad; undeclared fish allergen.
2 products
Tiki Bar Dark Chocolatey Peanut Butter & Pretzel is recalled for an undeclared peanut allergen.

Woodland Foods is recalling 55 lb. bags of Arrowroot Flour due to the potential presence of foreign material.

Saputo recalls Clover Sonoma and Great Value cottage cheese and sour cream over potential under-pasteurization.
5 products
Elite Treats is recalling All Natural Chicken Chips for Dogs due to potential Salmonella contamination.

Oregon Potato Company is recalling IQF blueberries in 30 lbs. cases and 1400 lbs. totes due to potential Listeria monocytogenes contamination.

Lubna Quality Products is recalling 4 lb mung bean packages due to unapproved pesticide (Thiamethoxam) contamination.

Medline is recalling kits containing Tego Connectors due to potential silicone seal defects that may cause fluid leakage or therapy delays.
6 products
Encore Medical is recalling EMPOWR 3D Knee and RSP Humeral Socket implants due to incorrect labeling.
3 products
Edermy is recalling PIE PAK trolley systems (models P2HC-A, P2HC-S, P2HC) due to a lack of required 510(k) clearance.
2 products
Slate Run Pharmaceuticals recalls Eptifibatide Injection 75 mg/100 mL vials (NDC 70436-027-80, 70436-163-80) due to incorrect dosing-route labeling.

AvKARE is recalling Amantadine HCl Capsules 100 mg (NDC 50268-069-15) nationwide due to failed dissolution specifications.

LEO Pharma is recalling Adbry (tralokinumab-ldrm) injection due to a lack of sterility assurance following the discovery of wool fiber.

Made Fresh Salads recalls 14 varieties of 5 lb whipped cream cheese over possible Listeria contamination.
14 products
Gerber Arrowroot Biscuits (5.5 oz, UPC 015000005962) recalled for potential paper/plastic contamination in arrowroot flour.

Hitachi recalls Proton Beam Therapy System over patient positioning software anomaly.
2 products
MCS and Lullaby Lane children's sleepwear are recalled for violating federal flammability standards, posing a burn hazard.

JJGoo LED balloon lights (Model MY1005E-Colorfu1-100) are recalled due to a serious battery ingestion and chemical burn hazard to children.

Huaker magnetic toy building sets (Model 20A-13) are recalled due to a serious choking hazard from small balls.

Joly's 80% Vinegar is recalled for missing mandatory safety labels, posing risks of poisoning and chemical burns.

Prismatic 3D Prints is recalling Book Nooks because their spare coin batteries are easily accessible, posing a serious ingestion hazard.

Vive Health is recalling models LVA1024 and LVA3031BLK bed rails due to a serious entrapment and asphyxiation risk.

SAMIT youth multi-purpose helmets are recalled for failing federal safety standards, posing a risk of serious head injury or death.
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
MG Foods recalls Spicy Breakfast Burrito 10 oz over possible plastic fragments.

Aonic recalls His & Hers supplement shots over possible E. coli and coliform contamination.
2 products
H & N Group is recalling 1 lb bags of frozen cooked medium shrimp due to potential Cesium-137 contamination.

McCain Foods recalls Ore-Ida Tater Tots and Sonic Tots over possible small hard plastic fragments.
2 products
Red Button Movie House Popcorn is being recalled due to the potential presence of foreign material.

Domino Foods recalls Sodexo Stars Saccharin Packets due to undeclared aspartame.

Kirkland Signature Mini Beignets are recalled due to undeclared hazelnut, which poses a risk to consumers with allergies.

Accord BioPharma is recalling Udenyca injection due to improper storage temperature conditions.

American Health Packaging is recalling Oxycodone 5 mg tablets due to defective blister card seals that may cause tablets to fall out.

Meitheal Pharmaceuticals is recalling Cetrorelix Acetate injection kits due to missing or duplicated needles in the delivery system.

Olympus is recalling the UHI-3 High Flow Insufflation Unit due to a software issue that may cause dangerous overpressure events.
3 products
Laerdal is recalling LCSU 4 RTCA suction units due to potential electromagnetic noise levels exceeding regulatory limits.

Quest Cat Food recalled for inadequate thiamine levels; stop feeding and contact Steve's Real Food.
2 products
Medline is recalling various surgical and biopsy convenience kits due to potential issues with the sterility assurance level.
62 products
Auris Health is recalling MONARCH Platform Bronchoscopy systems due to a software issue that may cause unexpected robotic arm repositioning and contact with the patient.

Stryker is updating the MOLLI 2 System labeling due to the risk of magnetized surgical tools dislodging markers during tissue removal.
2 products