Recall
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All recalls8,436 total

T
Tandem Diabetes Care, Inc. — Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911; t:slim X2 GS Classic, Replacement, Refurbished, REF: 1003808; t: slim X2, Basal-IQ

Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.

S
Shang Hao Jia, Inc — Soda Biscuit (Quinoa Chia Seed Flavor), Net Wt: 360g/12.07oz; Shelf life: 10 months; Manufacturer: Zhejiang Dinggian Industrial Co., Ltd. Importer: Shang Hao Jia., Inc. UPC: 6 970

Various snack cracker products are mislabeled and do not declare all allergen ingredients (Whole Milk Powder and wheat).

M
Middlefield Original Cheese Cooperative — 1) Middlefield Original Cheese Co-op 100% Grass-Fed Pepper Jack Cheese, 8 oz. individual units, 5 lb. loaves, and 40 lb. loaves, packaged in plastic with lot

Potential contamination with Listeria monocytogenes

M
Middlefield Original Cheese Cooperative — 1) Middlefield Original Cheese Co-op Monterey Jack Cheese, 8 oz. individual units, 5 lb. loaves, and 40 lb. blocks, packaged in plastic 2) Middlefield Origin

Potential contamination with Listeria monocytogenes

S
Shang Hao Jia, Inc — Soda Biscuit (Sea Salt Fresh Milk Flavor), Net Wt: 360g/12.07oz; Shelf life: 10 months; Manufacturer: Zhejiang Dinggian Industrial Co., Ltd. Importer: Shang Hao Jia., Inc. UPC: 6

Various snack cracker products are mislabeled and do not declare all allergen ingredients (Whole Milk Powder and wheat).

S
Shang Hao Jia, Inc — Soda Biscuit (Rye Flavor), Net Wt: 360g/12.07oz; Shelf life: 10 months; Manufacturer: Zhejiang Dinggian Industrial Co., Ltd. Importer: Shang Hao Jia., Inc. UPC: 6 970425 865055

Various snack cracker products are mislabeled and do not declare all allergen ingredients (Whole Milk Powder and wheat).

H
Herbalife International of America — Herbalife Nutrition, Relaxation Tea, Net Wt: 1.69 OZ (48g) UPC# L044KUS0A-00

Incorrect ingredient was received from supplier and used in manufacturing finished product Relaxation Tea.

M
Middlefield Original Cheese Cooperative — Paneer Cheese, Net Wt. 30 lbs., packaged in 5 lb. vacuum-sealed plastic bags with lot code 2517061, packed 6 bags per white cardboard case with packed on date

Potential contamination with Listeria monocytogenes

W
W.W. Industrial Group, Inc. — Parashore Pear Slices in Juice, 15 oz. (425 g), UPC#704817164237

Contaminated with elevated lead and cadmium

M
Middlefield Original Cheese Cooperative — Middlefield Original Cheese Co-op Horseradish Flavored Cheese, 8 oz. individual units, packaged in plastic with lot code 2524061

Potential contamination with Listeria monocytogenes

A
Ascend Laboratories, LLC — Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC

Failed Dissolution Specifications: low dissolution results

M
Merck & Co. Inc — Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 000

Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.

Y
YANGZHOU YULOU PAPER PRODUCTS CO., LTD — Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.

cGMP Deviations

D
Diagnostica Stago, Inc. — STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quanti

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

D
Diagnostica Stago, Inc. — STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting,

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

D
Diagnostica Stago, Inc. — STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quant

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

D
Diagnostica Stago, Inc. — STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 kit is intended for use with the analyzers of the STA-R, STA Compact and STA Satellite families fo

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

B
B.Braun Medical S.A.S. — Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,

The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.

S
SUMMA THERAPEUTICS, LLC — Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guid

Potential for the balloon in the device to not meet burst specifications.

I
Insightra Medical Inc — Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not ap

Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training.

E
Encore Medical, LP — Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non Sterile

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

K
King Cheesecake Company, Inc. — Item #3145 Hummingbird Layer Cake

Pecans have the potential to be contaminated with Salmonella

K
King Cheesecake Company, Inc. — Item #99273 chocolate Tres Leches Cheesecake

Pecans have the potential to be contaminated with Salmonella

K
King Cheesecake Company, Inc. — Item #2485 Assorted layer cake

Pecans have the potential to be contaminated with Salmonella

K
King Cheesecake Company, Inc. — Item #1312 Carrot layer cake

Pecans have the potential to be contaminated with Salmonella

K
King Cheesecake Company, Inc. — Item #99272 Tres Leches Cheesecake

Pecans have the potential to be contaminated with Salmonella

K
King Cheesecake Company, Inc. — Item #1071 Italian layer cake

Pecans have the potential to be contaminated with Salmonella

A
AEQUITA PHARMACY — Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Ph

Lack of Processing Controls.

A
AEQUITA PHARMACY — Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do

Lack of Processing Controls.

A
AEQUITA PHARMACY — Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita

Lack of Processing Controls.

A
AEQUITA PHARMACY — Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharm

Lack of Processing Controls.

A
AEQUITA PHARMACY — Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharm

Lack of Processing Controls.

A
AEQUITA PHARMACY — Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita

Lack of Processing Controls.

A
AEQUITA PHARMACY — Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharma

Lack of Processing Controls.

A
AEQUITA PHARMACY — Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Ph

Lack of Processing Controls.

A
AEQUITA PHARMACY — Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita

Lack of Processing Controls.

A
AEQUITA PHARMACY — Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita

Lack of Processing Controls.

A
AEQUITA PHARMACY — Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Phar

Lack of Processing Controls.

A
AEQUITA PHARMACY — Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Phar

Lack of Processing Controls.

A
AEQUITA PHARMACY — Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Phar

Lack of Processing Controls.

E
Encore Medical, LP — Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are int

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

E
Encore Medical, LP — Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

E
Encore Medical, LP — Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-Sterile

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

C
C.R. Bard Inc — SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

C
C.R. Bard Inc — SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

A
Albertsons Companies LLC — READY MEALS DUO TUNA SALAD W/ CRACKERS

Potential contamination with Listeria monocytogenes.

C
Cesarina Bakery, Inc — SESAME SEED COOKIES Cesarina Cookies, Net Weight. 16 oz. (454g), packaged in plastic clam shell containers, 12 packages per master case. Dry storage.

Allergen not listed in the Contains statement: Sesame

A
Albertsons Companies LLC — READY MEALS TUNA SALAD CROISSANT SANDWICH

Potential contamination with Listeria monocytogenes.

A
Albertsons Companies LLC — READY MEALS TUNA SALAD SNACKER TRAY

Potential contamination with Listeria monocytogenes.

A
Albertsons Companies LLC — Jewel Osco CLUB SANDWICHES WITH SALAD

Potential contamination with Listeria monocytogenes.

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