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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
Everything Sprouts, LLC
Everything Sprouts Crunchy Protein Sprout Mix, containing Alfalfa Fenugreek, Cabbage, Mung, Adzuki, Lentils, Green Pea, Net Wt. 5.0 oz (142 g) UPC 0 87906-01018 7. everythingsprouts.com
Sprouts may be contaminated with STEC E. coli and/or Salmonella.
Stryker Sustainability Solutions
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Reusable access port system may crack or seperate during use.
Prince Bakery Inc
Prince ITALIAN BREAD; Sesame; ITALIAN & FRENCH BREAD, LARGE; NET WEIGHT 12 OZ. (340g); INGREDIENTS: ENRICHED BLEACHED FLOUR (WHEAT FLOUR, MALT BARLEY FLOUR< NIACIN, FERROUS SULFATE, THIAMINE MONONITRATE, RIBOFLAVIN, FOLIC ACID, POTASSIUM BROMATE), WATER, YEAST, SALT, VEGETABLE SHORTENING (PARTIALLY HYDROGENATED SOYBEAN, COTTONSEED AND/OR CANOLA OILS), DOUGH CONDITIONER [WHEY (MILK), CORN FLOUR, MONOCALCIUM PHOSPHATE, L-CYSTEINE HYDROCHLORIDE, POTASSIUM BROMATE] DEXTROSE, MONO-DIGLCYERIDES, DIACETYL, TARTARIC ACID ESTERS OF MONO-DIGLYCERIDES (DATEM), CORN SYRUP SOLIDS, POTASSIUM BROMATE, ENZYME, POLYSORBATE 60, SOY OIL, L CYSTEINE, PROPIONIC ACID, SODIUM PROPIONATE (A PRESERVATIVE), PHOSPHORIC ACID. MAY CONTAIN SESAME SEEDS; UPC 8 93601 00104 6; green and yellow bag. Both Large Italian and French breads are packaged in the same bags.
Sesame is not declared in the ingredient statement but is declared in the statement of identity.
Green Jeeva LLC
Organic Moringa Powder; 15kg/bag (bulk); Product code: GJ96
Moringa Powder ingredient positive for salmonella
Chiesi USA, Inc.
CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10.
Lack of Assurance of Sterility
Intersurgical Inc
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Devices could potentially be occluded or partially occluded.
Medline Industries, LP
Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2) BLOOD CULTURE KIT 2 W/CONNECT, Model Number: DYNDH1487A
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening.
CareFusion 213, LLC
BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applicators/case, Catalog Number bulk 930715NSB, NDC 54365-400-35; STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and Co.
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
Remel, Inc
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Reduced or no recovery of some strains of Neisseria gonorrhoeae.
Guardian Drug Co. Inc.
HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2.
Presence of foreign substance: small metallic particles in chewable tablets.
J and J Bunting, Inc
Lunds & Byerly's Curry Powder Sweet
Sesame Seeds White were labeled as Curry Powder Sweet.
JOHN B SANFILIPPO & SONS INC
Good & Gather Mexican Street Corn Trail Mix 8 oz bag UPC 085239270240, 8 bags per case
potential presence of Salmonella
D'Dioses Fruit Pops, Inc.
Ice Pop, D'Dioses Nuez, 1 Bar (81.7 g), with UPC 827912008548
May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.
PS Seasoning & Spices, Inc.
Ellsworth Sour Cream + Onion Seasoning, Part #: 180000113. Net Wt 25.00 lbs (11.3kg). PS Seasoning & Spices 216 W Pleasant St Iron Ridge WI 53035
Product was made with milk powder recalled by the supplier due to Salmonella contamination.
Blaine Labs Inc
TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
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.
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.
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.
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
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