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Recall classifications
What the class levels mean
The most serious. Reasonable probability that the product will cause serious adverse health consequences or death.
May cause temporary or medically reversible adverse health consequences. Remote probability of serious harm.
Unlikely to cause any adverse health consequence. Typically a labeling or technical violation.
Active recalls
Recent ongoing recalls
Uncle Ray's LLC
Lowes Foods sour cream and onion flavored potato chips, 8oz. bag, UPC 7 41643 05576 6, 9 retail units per case
Inaccurate nutritional data in Nutrition Facts including but not limited to, understated sodium content. Undeclared ingredients including but not limited to, monosodium glutamate.
Medline Industries, LP
THORACIC ROBOTS, DYNJ908777B
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Juniper Granola, LLC
Junebar Chocolate Cherry All Natural Snack Bar; INGREDIENTS: ORGANIC ALMOND BUTTER, DATE PASTE, ORGANIC BLACK BEANS, ORGANIC SWEET POTATOES, GLUTEN FREE ROLLED OATS, SEMI-SWEET SOY FREE VEGAN CHOCOLATE CHIPS (ORGANIC CANE SUGAR, UNSWEETENED CHOCOLATE, COCOA BUTTER), DRIED CHERRIES, ALMONDS; OAT FLOUR, COCOA POWDER, ORANGE ZEST, VANILLA EXTRACT (VANILLA BEAN EXTRACTIVES IN WATER, ALCOHOL), FLAX, CINNAMON, SEA SALT, BAKING POWDER; ALLERGEN WARNING: CONTAINS TREE NUTS (ALMOND, COCONUT), PRODUCED ON EQUPMENT ALSO HANDLING PEANUT, SESAME. PRODUCED IN A FACILITY THAT ALSO PROCESES GLUTEN PRODUCTS. KEEP REFRIGERATED; UPC: 8 60012 38462 4
Products contain undeclared milk and soy.
F.H. INVESTMENTS, Inc. (dba Asteria Health)
Testosterone, 100 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-1100-32.
Presence of Foreign substance - potential presence of metal particulate matter
Unichem Pharmaceuticals USA Inc.
Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIS LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India, Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC., East Brunswick, NJ 08816, NDC 29300-187-01
cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
McKesson
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactured by Accord BioPharma, Inc., 8041 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, NDC 69448-025-63
Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrectly in a controlled room temperature environment instead of the required refrigerated environment.
Vortex Surgical Inc.
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Prima Vera Nueva, Inc.
Mushroom, Spinach & Salsa Tamales with 2 Cheeses Ingredients: Organic Corn Flour Masa, Mushrooms, Spinach, Onions, Jalapenos, Jack and White Cheddar Cheese (pasteurized milk, cheese cultures, salt and enzymes), Butter, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate). Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes. Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz. UPC: 748732000249
Potential contamination with biological hazards (Listeria monocytogenes).
Elekta, Inc.
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
BHARAT BAZAR
SOMA KITCHEN NATURAL ASAFOETIDA Net Wt. 4 oz (0.25 lb) Product of India Manufactured for and Imported by: Bharat Bazar, Fremont, CA 94539 Use by : JULY-2027 Lot : NATL/ASFTP/G/24 (BB/ASFTP/G/24) UPC : 4 973993 173586 Ingredients :- Natural Hing
Undeclared wheat.
CareFusion 303, Inc.
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main, REF: 1155-00, BD Pyxis CII Safe ES, REF: 1116-00
Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.
B Braun Medical Inc
Blood Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. Y-TYPE BLOOD SET W/ 170 ?M FILTER 120 IN; Catalog Number: 490355.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
B Braun Medical Inc
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML 126 IN; Catalog Number: 490283.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Twin Sisters Creamery, LLC
Twin Sisters Creamery Whatcom Blue cheese, 2.5lb. round cheese wheel, made with raw milk and aged at minimum of 60 days. Ingredients: cultured raw cow's milk, salt, enzymes, penicillium roqueforti. Made in Ferndale, WA. www.twinsisterscreamery.com.
Raw milk Whatcom Blue cheese is recalled due to E. coli O103:H2.
ProRx LLC
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04
Lack of Assurance of Sterility
Medline Industries, LP
MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M; 6) AUGMENTATION #87-RF, REF DYNJ27319V; 7) BREAST AUGMENTATION PACK, REF DYNJ33977M; 8) BREAST RECONSTRUCTION-HOULE, REF DYNJ44852M; 9) BREAST PACK, REF DYNJ57527C; 10) TRANSGENDER MASTECTOMY 2, REF DYNJ58257G; 11) ISS MAJOR BREAST PACK, REF DYNJ58668D; 12) CHEST/BREAST PACK, REF DYNJ66495A; 13) MAJOR PLASTICS PACK, REF DYNJ67968B; 14) BREAST PACK, REF DYNJ68464A; 15) BREAST PACK, REF DYNJ68464B; 16) PLASTIC PACK, REF DYNJ83856; 17) PLASTIC PACK, REF DYNJ83856A; 18) PLASTIC PACK, REF DYNJ83856B; 19) BREAST PACK, REF DYNJ84332A; 20) ACH PLASTICS BREAST PK-LF, REF DYNJ85111; 21) BREAST-CHEST, REF DYNJ900294L; 22) PLASTICS MASTECTOMY, REF DYNJ904966C; 23) BREAST PLASTIC, REF DYNJ906638B; 24) BREAST-CHEST, REF DYNJ907141B; 25) BREAST RECONSTRUCTION PACK, REF DYNJ907791B; 26) BREAST RECONSTRUCTION PACK, REF DYNJ907791D; 27) BREAST HERNIA, REF DYNJ908058A; 28) CHEST BREAST KIT, REF DYNJ909203A; 29) PLASTIC, REF DYNJ909410; 30) PLASTIC, REF DYNJ910440; 31) BREAST -LF, REF DYNJ9426113N; 32) GP-PLASTIC BREAST ABD PACK-LF, REF PHS397064007D.
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
Southwind Foods LLC dba Great American Seafood Imports Co.
Tovala branded Frozen raw phosphate free shrimp; 5oz IQF bag UPC: 829944085788
Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.
Medline Industries, LP
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Fagron Compounding Services
bevacizumab (Avastin) Injection, 1.25mg/0.05mL (0.12 mL Fill), Sterile Single-Dose Syringe, Fagron Sterile Services, 8710 E 34th St N. Wichita, KS 67226
Lack of Assurance of Sterility
GenoGenix LLC
Reconstitution XO Solution for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692. Also labeled as manufactured for CELIA Health a) 5% Exosomes, 10 mL vial and b) 10% Exosomes, 5 mL vial, Extension Health a) 20% Exosomes, 10 mL vial, b) 10% Exosomes, 10 mL vial and Medical Health Institute (MHI), a) 10 % Exosomes, 2mL vial, 5mL vial, 10mL vial, b) 5% Exosomes, 2mL vial, 5mL vial, 10mL vial.
Lack of Assurance of Sterility
GenoGenix LLC
Glycine for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
Lack of Assurance of Sterility
GenoGenix LLC
GHK-Cu (Copper Peptide) for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Lack of Assurance of Sterility
Tropicale Foods, LLC
La Michoacana Coconut Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00001-3
Product label includes the ingredient CREAM but does not include Milk as the source.
Doehler North America, Inc.
Member's Mark FREEZE DRIED FRUIT VARIETY PACK 15 COUNT 5-0.35OZ (10g) STRAWBERRY POUCHES 5-0.42OZ (12g) BANANA POUCHES 5-0.25 OZ (10g) APPLE POUCHES NET WT 5.6OZ (160g) NO ADDED SWEETENERS ONE INGREDIENT ONLY PER PACK UPC 1 93968 50900 2
Listeria monocytogenes. During routine testing the firm received positive test results for Listeria monocytogenes.
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