
FDA•MODERATE
IBA Proton Therapy System PROTEUS 235
IBA PROTEUS 235 proton therapy systems may fail to stop beam delivery if external gating device signal is lost, risking patient mistreatment.

IBA PROTEUS 235 proton therapy systems may fail to stop beam delivery if external gating device signal is lost, risking patient mistreatment.

Kirkman recalls Vasocaine Spray and Zone 1/2 Lidocaine Creams over unsupported expiry dates.
3 products
Olympus is recalling the ShockPulse-SE Lithotripsy System generator due to a wiring issue that may cause treatment delays.
2 products
Vergani Pandoro Classico Gluten Free recalled due to possible Teflon fragments.

Medline is recalling the Nail Kit (model DYKM1528) because the included sterile saline wound wash may not meet sterility requirements.
5 products
Suzanna's Kitchen recalls 13,720 lbs of ready-to-eat grilled chicken breast fillets (lot 60104 P1382 287 5 J14) over possible Listeria contamination.

Bader Enterprises recalls Premium Food Jordan Almonds and Bubble Gum for undeclared wheat and FD&C Blue 1 & 2 Lake.
2 products
Major Pharmaceuticals is recalling Midodrine Hydrochloride Tablets 5 mg (NDC 0904-6818-06) due to inadequately sealed blister packaging.

Olympus is recalling the MAJ-210 single use biopsy valve due to the potential for rubber fragments to detach during use.
2 productsDatascope is updating the Instructions for Use for the CS300 IABP (software version C.01) to correct battery runtime and cycle specifications.
2 products
Diagnostica Stago is recalling the STA Liatest Free Protein S kit due to potential underestimation of protein S levels in normal plasma.

Acme United is recalling 22 varieties of BZK Antiseptic Towelettes due to manufacturing process deviations.
22 products
Harbin Jixianglong recalls semaglutide bulk API over CGMP validation failures.
2 productsB. Braun recalls 21G winged infusion sets due to risk of dull or broken needle tip.
3 products
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.

Aesculap is recalling the Minop Trocar 150mm because the shaft may be too long.

Siemens is recalling Atellica CH Urine Albumin tests (Material 11537225) due to falsely depressed results in high-concentration samples.

Punahele Jerky beef crisps recalled for undeclared soy allergen; best by 2/17/2027 or prior.
4 products
Savannah Bee Honey BBQ Sauce "Mustard" bottles may contain "Sweet" sauce with undeclared wheat and soy.

Teva recalls Metoprolol Succinate ER tablets (25-200 mg) over failed dissolution specs.
4 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.

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.

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
Sobico 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
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.

Rosina recalls frozen Bremer Italian Style Meatballs over possible metal contamination.

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 productsStratford 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